Consolidated Document 04/VBHN-BYT promulgating consolidated decree on management of medical equipment

DECREE

On management of medical equipment [1]

Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government, on the management of medical equipment[2], which took effect from January 1, 2022, and was amended and supplemented under:

The Government’s Decree No. 07/2023/ND-CP dated March 3, 2023, amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical equipment[3], which took effect from March 3, 2023.

The Government’s Decree No. 96/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment, which took effect from January 1, 2024.

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Investment dated June 17, 2020;

At the proposal of the Minister of Health;

The Government promulgates the Decree on management of medical equipment.[4]

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Decree provides for the management of medical equipment[5], including the classification of medical equipment[6]; the manufacture, clinical research, placement of medical equipment on the market, the purchase and sale, export, import of medical equipment, and the provision of services related to medical equipment[7]; the information and advertisement of medical equipment[8]; the management of medical equipment[9] prices, and the management and use of medical equipment[10] at medical establishments.

2. This Decree does not apply to:

a) Raw materials and semi-finished products used for manufacture of medical equipment[11], except raw materials containing narcotic substances and precursors;

b) Raw materials used for manufacture of medical equipment[12], which are samples of blood, serum, plasma, urine, fecal, body fluids or other human biological specimens that are subject to biosafety requirements upon import/export as prescribed by law;

c) Medical gases;

d) Fittings for medical equipment[13];

dd) Research Use Only (RUO) and Laboratory Use Only (LUO) products.

Article 2. Interpretation of terms

1. “Medical equipment” [14] means any instrument, implant, apparatus, material, in-vitro reagent and solution, or software that meets all the following requirements:

a) The equipment is intended by the owner of the medical equipment[15] to be used, whether separately or in combination with each other, for human beings for one or more of the following purposes:

- To diagnose, prevent, supervise, treat, and alleviate a disease or to compensate for an injury or trauma;

- To examine, replace, modify, or assist surgery activities or physiological processes;

- To support or sustain life;

- To control conception;

- To disinfect medical equipment[16];

- To provide information serving diagnosis, monitoring and treatment through the examination of human biological specimens.

b) The equipment does not use pharmacological, immunological, or metabolic mechanism of action in or on the human body, or if it is used, it may only assist the equipment to achieve any of the purposes as prescribed at Point a of this Clause.

2. In vitro diagnostic medical equipment[17] means a reagent, calibration solution, control material, instrument, apparatus, equipment or system or other products intended by the product owner to be used, whether separately or in combination, in vitro for the examination of human biological specimens.

3. Personalized medical equipment[18] means a medical equipment[19] that is specifically made in accordance with a medical practitioner’s written prescription, with specific designed characteristics intended for the sole use of a particular individual.

4. Fitting means a product that is intended specifically by its medical equipment[20] owner to be used together with a particular medical equipment[21] to enable or assist such equipment to achieve its intended purpose.

5. Medical equipment[22] owner means any organization or individual that:

a) Supplies the medical equipment under its/his/her own name, or under any trademark, design, trade name or other name or mark owned or controlled by it/him/her;

b) Is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying the medical equipment[24], or for assigning a purpose to such equipment[25].

Article 3. Principles of management of medical equipment[26]

1. The quality, safety and efficacy of the medical equipment[27] must be verified.

2. Adequate, accurate and timely information about specifications and intended purposes of medical equipment[28] and potential risks must be provided to the users.

3. The traceability of medical equipment[29] must be ensured.

4. Medical equipment[30] shall be managed in accordance with their classified level of risks and relevant national technical regulations and/or national standards issued or recognized by competent State management agencies or announced standards applied by organizations/individuals in accordance with the law provisions.

5. Medical equipment[31] which are measuring devices or radiation equipment must be managed in accordance with the law on measurement and the law on atomic energy and this Decree.

6. Chemicals and preparations intended solely for disinfection of medical equipment[32] shall be managed in accordance with this Decree. Chemicals and preparations intended for other purposes, in addition to the disinfection of medical equipment[33], shall be managed in accordance with the law on insecticidal and germicidal chemicals and preparations for medical and household use.

7. Medical equipment[34], raw materials or ingredients used for manufacturing of medical equipment[35], and substances for external quality assessment that contain narcotic substances and precursors must be managed in accordance with the law on drug control, if they are imported or exported, and this Decree.

8. The provisions on classification, issuance of registration number, and declaration of eligibility for trading medical equipment as prescribed in this Decree shall not apply to:

a) Software used for medical equipment[36];

b) Medical equipment[37] traded as normal goods and imported as gifts or presents given to individuals or organizations other than health facilities.

Chapter II

CLASSIFICATION OF MEDICAL EQUIPMENT[38]

Article 4. Classification of medical equipment[39]

Medical equipment[40] shall be classified into the following 4 types according to their levels of potential risks related to their designs and manufacture[41]:

1. Type-A medical equipment[42] are those[43] at low level of risks.

2. Type-B medical equipment[44] are those[45] at low-moderate level of risks.

3. Type-C medical equipment[46] are those[47] at moderate-high level of risks.

4. Type-D medical equipment[48] are those[49] at high level of risks.

Article 5. Principles of management of medical equipment[50]

1. The classification of medical equipment[51] must be conducted the basis of their classified levels of risks.

2. Any medical equipment[52] which only has one intended purpose but is classified into two or more levels of risks shall be classified into the type representing the highest level of risks.

3. Any medical equipment[53] which has multiple intended purposes, each of which represents various levels of risks, shall be classified into the type representing the highest level of risks.

4. In cases where the medical equipment[54] is designed to be used in combination with another medical equipment[55], each of such medical equipment[56] shall be classified separately.

In vitro diagnostic medical equipment[57] which are equipment or systems used in testing process as well as reagents, titrants, calibration solutions or control materials may be classified into separate levels of risks but shall be classified into the type representing the highest level of risks posed by the final purpose of the combination of such medical equipment[58]. In vitro diagnostic medical equipment[59] which are other products being used in or supporting testing process may be classified into separate levels of risks.

5. The Minister of Health shall detail the classification of medical equipment[60] in accordance with the Association of South East Asian Nations (ASEAN) treaties on classification of medical equipment[61] to which Vietnam is a signatory.

6. The classification of medical equipment[62] must be conducted by the classification bodies whose names are specified in the declarations of applicable standards or circulation registration certificates.

Article 6. Cancellation of medical equipment[63] classification results

1. Medical equipment[64] classification results shall be cancelled in the following cases:

a) The incorrect classification results reduce the level of risks of the medical equipment[65];

b) The records of classification results are found fraudulent.

2. Procedures for cancellation:

a) Within 01 working day from the date on which conclusion of the classification results falling into one of the cases as prescribed in Clause 1 of this Article is given, the Ministry of Health shall issue a written decision on cancellation of classification results, which requests the classification body to take measures to remedy the consequences caused by its violations (if any) and remove the information on the cancelled medical equipment [66] classification result from the Portal on Management of Medical Equipment [67].

Copies of the written decision on cancellation of medical equipment [68] classification results shall be sent to the classification body, the provincial-level Departments of Health, General Department of Customs, and border-gate customs offices, and published on the Portal on Management of Medical Equipment [69].

b) After receiving the decisions on cancellation of classification results, the classification body shall cancel all classification results specified in the cancellation decision and take measures to remedy the consequences caused by its violations.

c) After receiving the decisions on cancellation of classification results, the authority that has received the application dossiers for declaration of applicable standards or the application dossiers for circulation registration (hereinafter referred to as “application dossiers for circulation number”) shall review the circulation numbers issued by itself. The authority that has granted the circulation numbers shall follow procedures for revoking the circulation numbers of medical equipment[70] that have been issued using classification results specified in the Ministry of Health’s decisions on cancellation of medical equipment[71] classification results.

Article 7. Handling of medical equipment[72] whose classification results are cancelled

1. In cases where a medical equipment[73] whose classification result is cancelled is applied for the grant of the circulation number:

a) The organization or individual shall submit an application dossier for circulation number shall send a written request to the authority receiving such application dossier for circulation number to suspend procedures for grant of circulation number.

b) After receiving the written request from the organization or individual as prescribed at Point a of this Clause, or after receiving the decision on cancellation of medical equipment[74] classification results, the authority receiving the application dossier shall refuse to grant the circulation number.

2. In cases where a medical equipment[75] whose classification result is cancelled has been granted the circulation number but has not been granted customs clearance:

a) The circulation number holder shall stop following procedures for customs clearance, send a written request to the border gate customs office where the goods clearance is expected to be carried out to suspend procedures for customs clearance, and the circulation number issuer to revoke the issued circulation number.

b) After receiving the written request from the circulation number holder or the decision on cancellation of medical equipment[76] classification results, the customs office shall suspend procedures for customs clearance, and the circulation number issuer shall follow procedures to revoke the issued circulation number.

3. In cases where a medical equipment[77] whose classification result is cancelled has been granted the circulation number and customs clearance but has not been purchased:

a) The circulation number holder shall:

- Stop placing the medical equipment[78] on the market and recall the medical equipment[79] granted the circulation number using the classification result that has been cancelled;

- Send a report to the customs office that granted customs clearance, in which the quantity of the medical equipment[80] that has been granted customs clearance must be specified, and do not follow procedures for import of the following shipments until the relevant medical equipment[81] is granted a new circulation number using the correct classification result;

- Send a written report to the circulation number issuer, in which the quantity of the medical equipment[82] that has been granted customs clearance must be specified, together with the purchase and sale contracts (if any);

- Reapply for the circulation number.

b) After receiving the circulation number holder’s written request or the decision on cancellation of medical equipment[83] classification results:

- The customs office shall refuse to grant customs clearance;

- The circulation number issuer shall carry out procedures for revoking the issued circulation number.

4. In cases where the medical equipment[84] has been sold to health facilities:

a) The circulation number holder shall:

- Send a written report to the circulation number issuer, in which the quantity of the medical equipment[85] that has been sold to health facilities must be specified;

- Send written notices to the health facilities that purchased the medical equipment[86].

b) In cases where the medical equipment[87] granted the circulation numbers using incorrect classification results do not pose threats to patients’ heath, the health facilities may keep using such medical equipment[88] and the circulation number holder shall supplement the documents about registration of such medical equipment[89] after new circulation numbers are granted.

b) In cases where the medical equipment[90] granted the circulation numbers using incorrect classification results is found to pose threats to patients’ heath, the health facilities shall stop using such medical equipment[91] and the circulation number holder shall implement necessary remedial measures for ensuring normal operation of such health facilities.

Chapter III

MANUFACTURE OF MEDICAL EQUIPMENT[92]

Article 8. Requirements for quality control by medical equipment[93] manufacturers

1. Their quality control systems must comply with ISO 13485.

2. A manufacturer of the medical equipment[94] that contains narcotic substances and precursors shall, in addition to the requirements prescribed in Clause 1 of this Article, also meet the following requirements:

a) Having a system for monitoring the dispatching, warehousing, inventory and use of narcotic substances and precursors as well as the medical equipment[95] and raw materials containing narcotic substances and precursors;

b) Medical equipment[96] and raw materials containing narcotic substances and precursors must be safely stored in a separate area in the same warehouse or in a separate warehouse.

Article 9. Application dossiers for declaration of eligibility for manufacture of medical equipment[97]

An application dossier for declaration of eligibility for manufacture of medical equipment[98] comprises:

1. A written declaration of eligibility for manufacture of medical equipment.

2. A certificate of conformity with ISO 13485 issued by a conformity assessment body as prescribed by law.

3. Documents proving the satisfaction of eligibility requirements prescribed in Clause 2, Article 8 of this Decree.

Article 10. Requirements for application dossiers for declaration of eligibility for manufacture of medical equipment[99]

1. An application dossier for declaration of eligibility for manufacture of medical equipment[100] shall be prepared as 01 set, in which:

a) Documents included in the application dossier must be clearly printed and arranged in the order as prescribed in Article 9 of this Decree; each document shall include content sections separated by section breaks, have cover pages, and be listed in a list of documents.

b) Documents in a language other than English and Vietnamese must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

2. Requirements for several documents in an application dossier for declaration of eligibility for manufacture of medical equipment:

a) The original of the certificate of conformity with quality control standards, or its certified true copy, or a copy certified by the applicant for declaration of eligibility for manufacture must be included in the dossier.

b) The originals of documents proving the applicant’s satisfaction of eligibility requirements as prescribed in Clause 2, Article 8 of this Decree, certified by the applicant for declaration of eligibility for manufacture, must be included in the dossier.

Article 11. Procedures for declaration of eligibility for manufacture of medical equipment[101]

1. Before initiating manufacture of medical equipment[102], the manufacturer shall submit a dossier for declaration of eligibility for manufacture of medical equipment[103] to the provincial-level Department of Health where its factory is located (the determination of the manufacturer’s factory shall be based on the location specified in its certificate of quality control system). In cases where there are multiple factories located in different provinces, the declaration shall be conducted in each province.

2. After receiving the application dossier (including the receipt of application fee as prescribed by the Ministry of Finance), the provincial-level Department of Health where the medical equipment[104] factory is located shall publish on the Portal on Management of Medical Equipment [105] all information about such application dossier for declaration of eligibility for manufacture of medical equipment[106].

3. During its operation, the manufacturer shall prepare a notice of changes enclosed with documents related to such changes and update such documents to its application dossier for declaration published on Portal on Management of Medical Equipment [107] within 03 working days from the occurrence of such changes.

Chapter IV

CLINICAL TRIALS ON MEDICAL EQUIPMENT[108]

Article 12. Clinical trial stages for medical equipment[109]

1. Clinical trial stages for medical equipment other than in vitro diagnostic medical equipment:

a) Stage 1: The first stage to conduct the preliminary research on the safety of medical equipment for humans and its usability for doctors and healthcare staff;

b) Stage 2: The confirmatory research to ascertain and establish evidence for the safety and efficacy of medical equipment;

c) Stage 3: The stage conducted after the medical equipment is placed on the market in order to collect more evidence for the safety and efficacy of the medical equipment during application upon request of competent state management authorities.

2. Clinical trial stages for in vitro diagnostic medical equipment:

a) Stage 1: The stage of assessing the clinical performance of in vitro diagnostic medical equipment;

b) Stage 2: The stage conducted after in vitro diagnostic medical equipment is placed on the market in order to collect more evidence for the safety and efficacy of in vitro diagnostic medical equipment during application upon request of competent state management authorities.

Article 13. Cases of exemption from clinical trials or from several stages of clinical trials for medical equipment before registration for circulation of medical equipment[110]

1. Medical equipment may be exempt from clinical trials in the following cases:

a) Medical equipment of types A and B;

b) Medical equipment of types C and D that has been licensed for circulation by the Ministry of Health of Vietnam or a competent foreign authority.

2. Domestically-manufactured medical equipment other than in vitro diagnostic medical equipment of types C and D shall be exempt from stage-1 clinical trial when they meet the following conditions:

a) Applying the transferred technology that already has medical equipment licensed for circulation by a competent authority, except in the case where the circulation license has been revoked;

b) Having the same indication for use as the medical equipment licensed for circulation by a competent authority specified at Point a of this Clause.

3. The Ministry of Health shall decide on exemption from clinical trials, and exemption from one or several stages of clinical trials for medical equipment serving urgent requirements for national defense, security, disease prevention and control, and remediation of consequences in case of disasters and catastrophes.

Article 14. Requirements for medical equipment[111] subject to clinical trials

1. Meeting the legal and technical requirements of dossiers of registration for circulation of medical equipment in accordance with regulations.

2. Labels of medical equipment used for clinical trial must contain the words "Medical equipment used for clinical trial, prohibited for other purposes". The labeling of medical equipment shall comply with the law on labeling of goods.

Article 15. Requirements for clinical trial-hosting establishments for medical equipment[112]

1. Meeting the requirements for good clinical practice of medical equipment trials in accordance with regulations of the Minister of Health.

2. Having the function of scientific research and the scope of professional activities appropriate to the medical equipment subject to clinical trials.

3. Being a legal entity that is independent in terms of organization, personnel, and finance from the organization or individual that has the medical equipment subject to clinical trials.

Article 16. Clinical trial dossiers for medical equipment[113]

1. A clinical trial dossier for medical equipment shall include the following types: dossier of application for clinical trial approval; dossier of application for approval of clinical trial changes; dossier of application for approval of medical equipment clinical trial results. The composition of each type of dossier shall comply with the provisions of Article 17 of this Decree.

2. Requirements for dossiers:

a) Clinical trial dossiers for medical equipment must be made in Vietnamese. If the dossier is not made in Vietnamese, there must be a certified translation of the dossier into Vietnamese.

b) Documents issued by foreign regulatory authorities shall be consularly legalized in accordance with the law on consular legalization, unless otherwise consular legalization is exempted in accordance with the law.

Article 17. Composition of clinical trial dossiers for medical equipment[114]

1. A dossier of application for medical equipment clinical trial approval comprises:

a) A written request for approval of clinical trials from organizations or individuals that have medical equipment subject to clinical trials.

b) A written request for approval of clinical trials from clinical trial-hosting establishments for medical equipment.

c) A written request from competent state management authorities for medical equipment subject to stage-3 clinical trial or for in vitro diagnostic medical equipment subject to stage-2 clinical trial.

d) A dossier of information about medical equipment subject to clinical trials, including

- Product information record (general information about medical equipment subject to clinical trials: name; characteristics; utilities; indications, contraindications; technical specifications and other related information);

- Pre-clinical research documents of medical equipment subject to clinical trials: research reports on safety, effectiveness, recommendations on usage and storage; research reports on stability and analytical performance (for in vitro diagnostic medical equipment) that are assessed as satisfactory by a clinical trial-hosting establishment or pre-clinical research establishment certified by the Ministry of Health;

- Research documents for clinical trials for medical equipment in the stages before the trial proposal stage.

dd) A legal dossier, comprising:

- Information about the owner, manufacturer and manufacturing processes of medical equipment;

- Technical documents of medical equipment;

- Technical standards of medical equipment announced by the medical equipment owner;

- Satisfactory quality assessment results for technical standards of medical equipment issued by a qualified establishment in accordance with the law on conformity assessment or a quality assessment certificate granted by a Vietnamese competent authority;

- Use instructions licensed for circulation for medical equipment requested for stage-3 clinical trials;

- A written confirmation of participation from the clinical trial participant;

- A clinical trial contract for medical equipment between the authority, organization or individual that has the medical equipment subject to clinical trials and the clinical trial-hosting establishment; research support contract between the organization or individual that has medical equipment subject to clinical trials and the research support organization (if any).

e) A scientific dossier, comprising:

- Explanation of clinical trials for medical equipment;

- Case report form (CRF);

- Summary of research information and volunteer forms of participation in research of medical equipment clinical trial participants.

g) An administrative dossier, comprising:

- A scientific curriculum vitae and a copy of the principal researcher's certificate of completion of the Good Clinical Practice course granted by the Ministry of Health or by institutions providing training programs in good clinical practice;

- A minute of appraisal of science and ethics in research by the ethical committee in the grassroots biomedical research;

- Equipment labels as specified in Clause 2, Article 14 of this Decree and use instructions of research medical equipment.

2. Dossiers of application for approval of changes in medical equipment clinical trials:

a) For administrative changes and changes in contact information of the clinical trial-hosting establishment: such establishment shall report to the Ministry of Health to summarize information.

b) For changes in the principal investigator or the clinical trial-hosting establishment, a dossier shall comprise:

- A written request for approval of changes in medical equipment clinical trials;

- Evidence documents for corresponding changes.

c) For changes not falling into the cases specified at Points a and b of this Clause, a dossier shall comprise:

- A written request for approval of changes in medical equipment clinical trials;

- The updated versions of the respective documents specified in Clause 1 of this Article which have been changed.

3. A dossier of application for approval of medical equipment clinical trial results shall comprise:

a) A written request for approval of medical equipment clinical trial results;

b) A copy of the approved clinical research protocol;

c) A copy of the decision approving the clinical trial;

d) A minute of appraisal of medical equipment clinical trial results of the ethics committee in the grassroots biomedical research;

dd) A report on clinical trial results of medical equipment.

Article 18. Process and procedures for approval of clinical trials[115]

1. A clinical trial-hosting establishment shall send directly, online or by post 01 dossier for approval of a clinical trial to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which it is received. If the dossier is valid, within 02 working days, the Ministry of Health shall transfer the dossier to the National Ethics Council for appraisal and evaluation of the ethical aspects of the research. If the dossier is invalid, within 02 working days, there must be a written notification and specific instructions for the establishment to supplement the dossier.

The clinical trial-hosting establishment shall be responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the written notification. After this time limit, the clinical trial approval procedures must be conducted again from the beginning.

3. The National Ethics Council shall conduct appraisal and evaluation of ethical aspects in research on a monthly basis.

4. Within 05 working days from the date of receiving the certificate of clinical trial approval from the National Ethics Council and accompanying dossiers, the Ministry of Health shall decide on approval for the clinical trial.

Article 19. Process and procedures for approval of clinical trial changes[116]

1. A clinical trial-hosting establishment shall send directly, online or by post 01 dossier for approval of clinical trial changes to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which it is received. If the dossier is invalid, within 02 working days, the Ministry of Health shall issue a written notification and specific instructions for the establishment to supplement the dossier.

The clinical trial-hosting establishment shall be responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the written notification. After this time limit, the procedure for approval of clinical trial changes must be conducted again from the beginning.

3. For the changes specified at Point b, Clause 2, Article 17 of this Decree: within 07 working days from the date of receiving a complete and valid dossier, the Ministry of Health shall decide on approval of clinical trial changes.

4. For the changes specified at Point c, Clause 2, Article 17 of this Decree:

a) In cases where the application dossier is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for review;

b) The National Ethics Council shall conduct appraisal and evaluation of ethical aspects in research on a monthly basis;

c) Within 05 working days from the date of receiving the certificate of approval of clinical trial changes from the National Ethics Council and accompanying dossiers, the Ministry of Health shall decide on approval of clinical trial changes.

Article 20. Process and procedures for approval of clinical trial results[117]

1. A clinical trial-hosting establishment shall send directly, online or by post 01 dossier for approval of clinical trial results to the Ministry of Health.

2. The Ministry of Health shall check the validity of the application dossier within 05 working days from the date on which it is received. In cases where the application dossier is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for review. If the dossier is invalid, within 02 working days, the Ministry of Health must issue a written notification and specific instructions for the establishment to supplement the dossier.

The clinical trial-hosting establishment shall be responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the written notification. After this time limit, the procedures for approval of clinical trial changes must be conducted again from the beginning.

3. The National Ethics Council shall conduct appraisal and evaluation of ethical aspects in research on a monthly basis.

4. Within 05 working days from the date of receiving the certificate of approval for clinical trial results from the National Ethics Council and accompanying dossiers, the Ministry of Health shall decide on approval for the clinical trial.

Chapter V

PLACEMENT OF MEDICAL EQUIPMENT ON THE MARKET[118]

Section 1. CIRCULATION NUMBER, CONDITIONS FOR CIRCULATION AND REQUIREMENTS FOR ORGANIZATIONS DECLARING APPLICABLE STANDARDS OR APPLYING FOR CIRCULATION NUMBER

Article 21. Circulation numbers of medical equipment[119]

1. Circulation numbers of a medical equipment[120] is:

a) The number of the declaration of applicable standards of Type-A or Type-B medical equipment[121];

b) The number of the certificate of circulation registration of Type-C or Type-D medical equipment[122].

2. [123] Circulation number holder is the organization that declares applicable standards for medical equipment[124] or that is granted the certificate of registration for circulation of medical equipment[125] in accordance with this Decree.

3. Validity of circulation number: The circulation number of a medical equipment[126] shall be valid for indefinite term, unless otherwise the circulation number of a medical equipment[127] is issued in accordance with the provisions on issuance of emergency-use circulation number for medical equipment[128] to serve pandemic prevention and control, catastrophe and disaster relief purposes. Based on the actual application dossier for issuance of emergency-use circulation number for the medical equipment[129], the Minister of Health shall decide the specific validity of the issued circulation number.

Article 22. Conditions for circulation of medical equipment[130] [131]

1. In order to be circulated in the market, medical equipment[132] must satisfy the following conditions:

a) Having been granted a circulation number, a circulation registration number, a circulation registration certificate or import license according to regulations on management of medical equipment [133] or falling into the case specified at Point d, Clause 2, Article 76 of this Decree, except:

- Medical equipment which are subject to liquidation in accordance with law;

- Medical equipment the shelf life of which has expired;

- Medical equipment of which the faults that adversely affect the users’ health cannot be remedied as specified in Clause 4, Article 34 of this Decree;

- Medical equipment the use of which is disallowed by competent state agencies.

b) Having labels with adequate information according to current regulations on goods labels;

c) Being accompanied by use instructions in Vietnamese for medical equipment[134];

d) Having information about the warranty service providers, and warranty conditions and duration, except disposable medical equipment[135] as specified by the owners of medical equipment[136] or unless there are documents proving that no warranty regime is applied.

2. For medical equipment that have been granted import licenses under Point a, b, c, d or dd, Clause 1, Article 48 of this Decree, the conditions specified at Point d, Clause 1 of this Article are not applied.

3. In case the information specified at Points c and d, Clause 1 of this Article does not accompany the medical equipment[137], it must be provided in the form of electronic information and the medical equipment[138]’ labels must display instructions for searching for information.

Article 23. Requirements for making declarations of applicable standards or issuing certificates of circulation registration for a medical equipment[139]

1. Requirements for making declarations of applicable standards or issuing certificates of circulation registration for a medical equipment[140]:

a) The medical equipment[141] is manufactured domestically by a manufacturer that has made declaration of eligibility for manufacture of medical equipment;

b) In cases where the medical equipment[142] is imported, it must be manufactured by a manufacturer that is granted a certificate of conformity with ISO 13485, and permitted to be circulated in every country in the world;

c) The medical equipment shall comply with national technical regulations or standards declared by the manufacturer.

2. Procedures for declaration of applicable standards or circulation registration of medical equipment[143] shall not be re-conducted in the following cases:

a) The medical equipment[144] falls in any of the cases prescribed in Clause 1, Article 37 of this Decree;

b) The medical equipment[145] is recalled in accordance with Clauses 1 and 3, Article 38 of this Decree.

3. Any application dossier for declaration of applicable standards or circulation registration of such medical equipment[146] submitted within 12 months from the date on which a medical equipment circulation number is revoked under a decision as prescribed in Clause 2, Article 38 of this Decree shall be rejected.

Article 24. Cases of exemption from declaration of applicable standards and exemption from circulation registration

1. The medical equipment[147], which is used for research, testing, inspection, experiment, quality evaluation, training and instruction for use or medical equipment[148] repair only.

2. The medical equipment[149] is imported into Vietnam to serve the purposes of emergency aid or provision of humanitarian medical services or to be displayed at trade fair, exhibition, or product launch event, to be used as gift given to a health facility, to be used for medical treatment of a particular individual, or to serve special diagnosis of a health facility.

3. Unregistered medical equipment[150] which is imported to serve pandemic prevention and control, or catastrophe and disaster relief and cannot be replaced by any other medical equipment[151] sold on the market.

4. Medical equipment[152] which is manufactured in Vietnam to serve the purposes of export or display at an overseas trade fair or exhibition only.

Article 25. Requirements for organizations declaring applicable standards or applying for circulation registration for medical equipment[153]

1. Organizations that declare applicable standards or apply for circulation registration for medical equipment[154] include:

a) Vietnamese enterprises, cooperatives or household businesses that are medical equipment[155] owners;

b) Vietnamese enterprises, cooperatives or household businesses that are authorized by medical equipment[156] owners;

c) Permanent representative offices in Vietnam of foreign traders that are medical equipment[157] owners or authorized by medical equipment[152] owners.

2. The organization declaring applicable standards or applying for circulation registration of a medical equipment[159] must establish and maintain a warranty center in Vietnam or sign a contract with a qualified medical equipment[160] warranty center, unless otherwise such medical equipment[161] is single-use medical equipment as defined by its medical equipment[162] owner or there are documents proving that it is not under warranty.

In cases where the organization declaring applicable standards or applying for circulation registration of a medical equipment[163] is any of the entities prescribed at Point c, Clause 1 of this Article, the medical equipment owner[164] must establish and maintain a warranty center in Vietnam or sign a contract with a qualified medical equipment[165] warranty center, unless otherwise such medical equipment[166] is single-use medical equipment as defined by its medical equipment[167] owner or there are documents proving that it is not under warranty.

The warranty center must be granted a certificate of eligibility for providing warranty services by the medical equipment[168] owner.

Section 2. DECLARATION OF APPLICABLE STANDARDS FOR TYPE-A OR TYPE-B MEDICAL EQUIPMENT[169]

Article 26. Application dossiers for declaration of applicable standards

An application dossier for declaration of applicable standards for Type-A or Type-B medical equipment[170] consists of:

1. A written declaration of applicable standards for Type-A or Type-B medical equipment[171].

2. A certificate of conformity with ISO 13485, which remains valid when the dossier is submitted.

3. A power of attorney, which remains valid when the dossier is submitted, given by the medical equipment[172] owner to the organization that applies for declaration of applicable standards, unless otherwise prescribed at Point a, Clause 1, Article 25 of this Decree.

4. A certificate of eligibility for providing warranty services granted by the medical equipment[173] owner, unless otherwise such medical equipment[174] is single-use medical equipment as defined by the medical equipment[175] owner or there are documents proving that it is not under warranty.

5. A synopsis of technical description of the medical equipment[176] in Vietnamese language, accompanied by technical documents describing functions and specifications of the medical equipment[177] issued by the medical equipment[178] owner.

For in-vitro diagnostic reagents, calibrators and control materials: Technical documents in Vietnamese, enclosed with documents on raw materials, product safety, manufacture processes, and clinical and preclinical research reports, including reports on stability.

6. A certificate of conformity as prescribed or a product standard sheet announced by the medical equipment[179] owner.

For a domestically manufactured medical equipment[180], the assessment record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with the law provisions on conformity assessment is required; or, for an in vitro diagnostic medical equipment[181], the certificate of quality assessment issued by a competent authority of Vietnam is required. The assessment result must be conformable with the standards declared by the medical equipment[182] owner.

7. Use instructions of medical equipment[183].

8. The specimen of the label to be used upon circulation in Vietnam of medical equipment[184].

9. A certificate of free sale (CFS) for imported medical equipment[185] which remains valid when the dossier is submitted.

Article 27. Requirements for application dossiers for declaration of applicable standards

1. An application dossier for declaration of applicable standards shall be prepared as 01 set.

2. Requirements for several documents included in the application dossier:

a) For the Certificate of conformity with quality control standards: to submit the original, certified true copy, or a copy certified by the organization declaring the applicable standards.

In cases where the Certificate of conformity with quality control standards is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

b) With regard to the power of attorney of the owner of medical equipment[186] and the certificate of eligibility to provide warranty:

- Regarding a domestically produced medical equipment[187]: the original copy or a certified true copy is required;

- Regarding an imported medical equipment[188]: to submit the consularly legalized copy or a certified copy of the consularly legalized copy.

c) For the certificate of conformity or the product standard sheet provided by the medical equipment[189] owner: to submit the original or a copy certified by the organization declaring the applicable standards.

In cases where the product standard sheet is not made in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with law.

d) For use instructions of medical equipment[190]: To submit the Vietnamese version certified by the organization declaring the applicable standards, enclosed with the English original issued by the owner of the medical equipment[191], for imported medical equipment[192]. In cases where the use instructions is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

dd) For the specimen of the label: to submit the specimen of the label certified by the organization declaring the applicable standards. The label specimens must meet the requirements of the law on goods labels.

e) For the CFS: to submit the consularly legalized copy or a certified copy of the consularly legalized copy.

In case the CFS is made in a language other than English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

g) For the record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with the law provisions on conformity assessment or the certificate of quality assessment issued by a competent agency of Vietnam, for an in vitro diagnostic medical equipment[193]: the original copy or a certified true copy is required.

Article 28. Procedures for declaration of applicable standards

1. Before placing any Type-A or Type-B medical equipment[194] on the market, the organization declaring applicable standards shall submit an application dossier for declaration to the Department of Health of the province where it is headquartered.

2. After receiving the application dossier (including the receipt of application fee as prescribed by the Ministry of Finance), the Department of Health of the province where the medical equipment[195] business facility is located shall publish the number of the declaration of applicable standards for such Type-A or Type-B medical equipment[196] on the Portal on Management of Medical Equipment[197] and the dossier of declaration of applicable standards, other than those prescribed in Clause 5, Article 26 of this Decree.

3. In cases where there are changes in the medical equipment[198] owner, the type of the medical equipment[199], its category, intended purposes or indications for use, or additional information about the manufacturer or product code is provided, the circulation number holder shall re-apply for declaration of applicable standards in accordance with this Decree.

4. During the circulation of the medical equipment[200], the owner that has declared applicable standards for such medical equipment shall send a written notice of changes, enclosed with documents related to such changes, and update them to its application dossier for declaration of applicable standards published on the Portal on Management of Medical Equipment[201] within 05 working days from the occurrence of any of the following changes:

a) Change in address of the owner of medical equipment[202] or a medical equipment[203] circulation number holder;

b) Change in name of the circulation number holder or the owner of medical equipment[204];

c) Change in name or address of the medical equipment[205] manufacturer;

d) Change in packaging specifications;

dd) Change of the warranty provider of medical equipment;

e) Change in the label or use instructions without changing its intended purposes or indications for use. If the medical equipment[206] has been manufactured before the owner declaring the applicable standards makes a written notice of change in the label, it may be circulated with the information declared at the date of manufacture;

g) Reduction of factories, category, or product code.

Section 3. CIRCULATION REGISTRATION OF TYPE-C OR TYPE-D MEDICAL EQUIPMENT[202]

Article 29. Methods of circulation registration

1. A new circulation number shall be issued for a medical equipment[208] in any of the following cases:

a) The medical equipment[209] is applied for grant of circulation number for the first time.

b) The medical equipment[210] has been granted circulation number but has any of the following changes:

- A change in the medical equipment[211] owner; medical equipment[212] type; category, intended purposes or indications for use; quality standards; addition of factories or product code; the raw materials that affect the functions of in vitro diagnostic medical equipment[213] or single-use medical equipment[214]; the concentration, content, composition of raw materials that are active ingredients combined in one medical equipment[215] to support the medical treatment;

- A change other than those prescribed in Clause 7, Article 32 of this Decree.

2. A new circulation number shall be issued for medical equipment[216] with shortened procedures in any of the following cases:

a) The medical equipment has been granted the CFS (Certificate of Free Sale) or marketing authorization by one of the following authorities or countries: the US Food and Drug Administration (FDA), Australian Therapeutic Goods Administration (TGA), Health Canada, Japanese Ministry of Health, Labor and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA), EU state members, the UK, Switzerland, Chinese National Medical Products Administration (NMPA), RoK Ministry of Food & Drug Safety (MFDS), or other CFS issuing authorities recognized by Vietnam (hereinafter referred to as reference countries);

b) The medical equipment has been granted the import license, circulation number, or certificate of circulation registration in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

3. An emergency-use circulation number shall be issued to a medical equipment[217] to serve pandemic prevention and control, catastrophe and disaster relief purposes in the emergency cases listed by the Minister of Health and any of the following cases:

a) The medical equipment has been permitted for circulation or granted registration number for emergency use in one of the reference countries;

b) The medical equipment is included in the list of products for emergency use announced by the World Health Organization (WHO);

c) The medical equipment is included in the list of common products announced by the EU Health Security Committee (EUHSC);

d) The medical equipment has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

dd) The medical equipment[218] is domestically manufactured in the form of technology transfer for medical devices in any of the cases prescribed at Points a, b, c or d of this Clause;

e) The medical equipment[219] is domestically manufactured in the form of medical equipment processing in any of the cases prescribed at Points a, b, c or d of this Clause.

Article 30. Application dossiers for issuance of new circulation numbers

1. An application dossier for issuance of a new circulation number of a medical equipment[220] corresponding to a national technical regulation consists of:

a) A written request for issuance of a new circulation number.

b) A certificate of conformity with ISO 13845, which remains valid when the dossier is submitted.

c) A power of attorney, which remains valid when the dossier is submitted, given by the medical equipment[221] owner to the organization that applies for circulation registration, unless otherwise prescribed at Point a, Clause 1, Article 25 of this Decree.

d) A certificate of eligibility for providing warranty services granted by the medical equipment[222] owner, unless otherwise such medical equipment is single-use medical equipment[223] as defined by the medical equipment[224] owner or there are documents proving that it is not under warranty.

dd) A CFS, which remains valid when the dossier is submitted, for an imported medical equipment[225].

e) An ASEAN Common Submission Dossier Template of medical equipment[226] (hereinafter referred to as “CSDT”).

g) A certificate of conformity.

h) Certificate of medical equipment clinical trial results granted by a competent authority for medical equipment[227] subject to clinical trials as specified in Clause 2, Article 94 of the Law on Medical Examination and Treatment.

2. An application dossier for issuance of a new circulation number for the medical equipment[228] that is a measuring device whose sample requires approval as prescribed by the law provisions on measurement consists of:

a) A written request for issuance of a new circulation number.

b) The decision on approval of the sample medical equipment.

c) [229] Documents as specified at Points b, c, d, dd, e and h, Clause 1 of this Article.

3. An application dossier for quick issuance of a new circulation number for the medical equipment[230] as prescribed in Clause 2, Article 29 of this Decree consists of:

a) A written request for issuance of a new circulation number.

b) Documents prescribed at Points b, c, and d, Clause 1 of this Article.

c) A CFS issued by one of the reference countries in the case prescribed at Point a, Clause 2, Article 29 of this Decree.

d) A CFS for an imported medical equipment[231], and an import license, circulation number, or certificate of circulation registration in the case prescribed at Point b, Clause 2, Article 29 of this Decree.

dd) A certificate of quality assessment issued by a competent agency of Vietnam for an in vitro diagnostic medical equipment[232], except the following cases:

- The medical equipment is included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Equipment[233] Regulation and has been granted a CFS by one of EU member states, the UK or Switzerland;

- The medical equipment is included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Equipment[234] Regulation and has been granted a Marketing Authorization by one of the reference countries;

- The medical equipment is not included in List A or List B of Annex 2 to the EU In Vitro Diagnostic Medical Equipment[235] Regulation and has been granted a Marketing Authorization by one of the reference countries;

- The medical equipment is included in the list of medical equipment announced by the Minister of Health.

e) A CSDT.

4. An application dossier for issuance of a new circulation number for the medical equipment[236] in an emergency case as prescribed in Clause 3, Article 29 of this Decree consists of:

a) A written request for issuance of a new circulation number.

b) Documents prescribed at Points b, c, and d, Clause 1 of this Article.

c) A CFS or license for emergency use of the imported medical equipment[237].

d) The contract for technology transfer for the case prescribed at Point dd, Clause 3, Article 29 of this Decree.

dd) The processing contract in the case prescribed at Point e, Clause 3, Article 29 of this Decree.

e) A certificate of inspection or a certificate of product quality assessment issued by one of entities listed on the Ministry of Health’s portal if the medical device falls in one of the following cases:

- Domestically produced medical equipment[238];

- The medical equipment[239] has been granted a permit for circulation or emergency use by a competent authority of one of EU member states, the UK or Switzerland but is not included in the EUHSC’s list of common products.

g) A CSDT.

h) [240]Certificate of medical equipment clinical trial results granted by a competent authority in the case where the clinical trial must be conducted in accordance with the law provisions.

5. An application dossier for issuance of a new circulation number for the medical equipment[241] in other cases consists of:

a) A written request for issuance of a new circulation number.

b) Documents prescribed at Points b, c, d and dd Clause 1 of this Article.

c) A record of the CSDT inspection given by the agency designated by the Minister of Health, enclosed with the CSDT.

d) For an in vitro diagnostic medical equipment[242] that is reagent, calibration solution or control material: A certificate of quality issued by a competent agency of Vietnam.

dd) For chemicals or preparations only used for disinfection of medical equipment[243]: A report on testing for active ingredients in the disinfectants and the contents thereof given by the entity that has declared its eligibility for providing testing services in accordance with the law provisions on management of insecticidal and germicidal chemicals and preparations for medical and household use; a report on trials to evaluate biological efficacy and side effects of the product on trial participants given by the entity that has declared its eligibility to conduct trials in accordance with the law provisions on management of insecticidal and germicidal chemicals and preparations for medical and household use.

e) [244]Certificate of medical equipment clinical trial results granted by a competent authority for medical equipment subject to clinical trials as specified in Clause 2, Article 94 of the Law on Medical Examination and Treatment.

Article 31. Requirements for application dossier for new circulation number

1. Requirements for a number of documents included in the dossier for registration:

a) For the Certificate of conformity with quality control standards: the original copy or a certified true copy or a copy bearing the applicant’s certification is required.

In cases where the Certificate of conformity with quality control standards is not made in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

b) With regard to the power of attorney of the owner of medical equipment[245] and the certificate of eligibility to provide warranty:

- Regarding a domestically produced medical equipment[246]: the original copy or a certified true copy is required;

- Regarding an imported medical equipment[247]: to submit the consularly legalized copy or a certified copy of the consularly legalized copy.

c) With regard to a marketing authorization: to submit the consularly legalized copy or a certified copy of the consularly legalized copy.

In cases where the marketing authorization is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

d) With regard to a quality assessment certificate, testing report, trial report and record of appraisal of CSDT dossiers: the original copy or a certified true copy or a copy bearing the applicant’s certification is required.

dd) With regard to a CSDT dossier: submit the copy with the certification of the applying organization. In case the CSDT dossier is made in a language other than English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

2. Requirements for a number of documents included in the dossier for circulation registration of medical equipment for emergency use as prescribed in Clause 3, Article 29 of this Decree:

Documents issued by foreign competent agencies must be consularly legalized. In cases where a document does not bear consular legalization:

a) With regard to the letter of authorization: the original copy accompanied by certification must be submitted.

b) With regard to the documents prescribed at Point c, Clause 4, Article 30 of this Decree: it must indicate the link for searching information on the circulation or license for use of medical equipment[248] on the licensing agency’s website, enclosed with a document providing the link for searching information of the applicant. The results of searching information on circulation license found on the website must include at least the following information in English: name, type, manufacturer and manufacturing country.

Article 32. Receipt and appraisal of dossiers for circulation registration of medical equipment[249]

1. The applicant shall submit an application dossier for circulation number to the Ministry of Health through the portal on management of medical equipment[250].

2. With regard to a dossier for circulation registration of medical equipment[251] prescribed in Clause 1 and Clause 2, Article 30 of this Decree:

a) If the dossier does not need to be modified or supplemented, the Minister of Health shall organize the appraisal to issue the circulation number within 30 days after receiving a complete and valid dossier (including the written confirmation of payment of the charge for appraisal and grant of circulation licenses according to the Ministry of Finance’s regulations); in case of refusal to issue a circulation number, it shall issue a written reply, clearly stating the reason.

b) In cases where the dossier is not complete, the Ministry of Health shall notify the applicant to supplement or amend a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 25 days from the receipt of the complete and valid dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has amended and supplemented such dossier but the modified application dossier is still unsatisfactory, the Ministry of Health shall notify the applicant to continue to complete the dossier in accordance with regulations at Point b, Clause 2 of this Article.

Within 90 days from the date on which the Ministry of Health issues the written request, if such applicant fails to amend, supplement the dossier or if after 05 times of amendment and supplement of the dossier from the date on which the Ministry of Health issues the first written request, the dossier is still unsatisfactory, the procedure to request for the registration number must be conducted from the beginning.

3. With regard to a dossier for circulation registration of medical equipment[252] prescribed in Clause 3, Article 30 of this Decree:

a) If the dossier does not need to be modified or supplemented, the Minister of Health shall organize the appraisal to issue the circulation number within 15 working days after receiving a complete and valid dossier (including the written confirmation of payment of the charge for appraisal and grant of circulation licenses according to the Ministry of Finance’s regulations). In case of refusal to issue a circulation number, a written reply, clearly stating the reason, is required.

The Ministry of Health shall only appraise the legal documents specified at Points b, c, d and dd Clause 1, Article 30 of this Decree. The applicant shall be accountable for the accuracy and legitimacy of other documents included in the dossier which may be inspected by the Ministry of Health after issuing the circulation number.

b) In cases where the dossier is not complete, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 12 days from the receipt of the complete and valid dossier.

c) [253]When receiving a request for supplementing or amending the dossier for grant of circulation number, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has amended and supplemented such dossier but the modified content is still unsatisfactory, the Ministry of Health shall notify to the applicant to continue to complete the dossier in accordance with Point b Clause 3 of this Article.

Within 90 days from the date on which the Ministry of Health notifies the request, if the applicant fails to amend or supplement the dossier or if after 03 times of amendment and supplement of the dossier from the date on which the Ministry of Health issues the first request, the dossier is still unsatisfactory, the procedure to request for the marketing authorization number must be carried out from the beginning.

4. With regard to a dossier for circulation registration of medical equipment[254] prescribed in Clause 4, Article 30 of this Decree:

a) If the dossier does not need to be modified or supplemented, the Minister of Health shall organize the appraisal to issue the circulation number within 10 working days after receiving a complete and valid dossier (including the written confirmation of payment of the charge for appraisal and grant of circulation licenses according to the Ministry of Finance’s regulations). In case of refusal to issue a circulation number, it shall issue a written reply, clearly stating the reason.

The Ministry of Health shall only appraise the legal documents specified at Points b, c, d, dd and e, Clause 4. Article 30 of this Decree. The applicant shall be accountable for the accuracy and legitimacy of other documents included in the dossier which may be inspected by the Ministry of Health after issuing the circulation number.

b) In cases where the dossier is not satisfactory, the Ministry of Health shall send a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 08 days from the receipt of the complete and valid dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has amended and supplemented such dossier but the modified application dossier is still unsatisfactory, the Ministry of Health shall notify the applicant to continue to complete the dossier in accordance with regulations at Point b, Clause 4 of this Article.

In cases where the applicant fails to supplement and amend the dossier within 90 days from the date the Ministry of Health sends the request for modification, the applicant shall re-perform the procedure for applying a circulation number.

5. With regard to a dossier for circulation registration of medical equipment[255] prescribed in Clause 5, Article 30 of this Decree:

a) If the dossier does not need to be modified or supplemented, the Minister of Health shall organize the appraisal to issue the circulation number within 45 days after receiving a complete and valid dossier (including the written confirmation of payment of the charge for appraisal and grant of circulation licenses according to the Ministry of Finance’s regulations); in case of refusal to issue a circulation number, it shall issue a written reply, clearly stating the reason.

b) In cases where the dossier is not complete, the Ministry of Health shall notify the applicant to supplement or amend a request for supplementing or amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant within 40 days from the receipt of the complete and valid dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has amended and supplemented such dossier but the modified application dossier is still unsatisfactory, the Ministry of Health shall notify the applicant to continue to complete the dossier in accordance with regulations at Point b, Clause 5 of this Article.

Within 90 days from the date on which the Ministry of Health issues the written request, if such applicant fails to amend, supplement the dossier or if after 05 times of amendment and supplement of the dossier from the date on which the Ministry of Health issues the first written request, the dossier is still unsatisfactory, the procedure to request for the registration number must be conducted from the beginning.

6. Within 01 working day from the issuance of the circulation number, the Ministry of Health shall publish the following information on the portal on management of medical equipment[256], including:

a) Name, type, manufacturer and manufacturing country of medical equipment[257];

b) Circulation number of medical equipment[258];

c) Name and address of the owner of medical equipment[259];

d) Name and address of the circulation number holder;

dd) Name and address of the warranty provider of medical equipment[260];

e) The documents included in the dossier for circulation registration of medical equipment[261], except the documents prescribed at Point e, Clause 1 and Point c, Clause 5 of Article 30;

g) Intended purposes of medical equipment[262].

7. During the circulation of the medical equipment[263], the circulation number holder shall prepare a written notice of changes, enclosed with documents related to such changes, and update them to its application dossier for declaration of applicable standards published on the Portal on Management of Medical Equipment[264] within 10 working days from the occurrence of any of the following changes:

a) Change in address of the owner of medical equipment[265] or a medical equipment[266] circulation number holder;

b) Change in name of the circulation number holder or the owner of medical equipment[267];

c) Change in the medical equipment[268] manufacturer’s name or address;

d) Change in packaging specifications;

dd) Change of the warranty provider of medical equipment;

e) Change in the label or user manual without changing intended purposes, indications for use, functions or performance of medical equipment[269]. Where the medical equipment[270] has been manufactured before the circulation number holder makes a notice of change in the label, the equipment may be circulated with information registered and updated at the date of manufacture.

Article 32a. Priorities in processing of dossiers of registration for medical equipment[271] circulation

1. A dossier of registration for medical equipment circulation may be given priority in the processing if it falls into one of the following cases:

a) Domestically-manufactured medical equipment;

b) Imported medical equipment for which a dossier of application for a medical equipment import license has been submitted to the Ministry of Health before January 1, 2022 but the medical equipment import license has not yet been granted, and a dossier of registration for grant of medical equipment circulation certificate has submitted;

c) Chemicals and preparations for only the purpose of sterilization of medical equipment;

d) Medical equipment to implement new techniques and new methods applied in medical examination and treatment that has been officially approved in writing by the Ministry of Health but has not yet been granted a circulation number in Vietnam;

dd) Medical equipment that has no change in information about types or product codes on the import license or decision to grant a circulation registration number or a valid circulation registration certificate but falls into one of the following:

- Changing the import establishment or circulation registration unit;

- Changing name of the manufacturer but not changing its address;

- Changing name of the medical equipment owner but not changing its address;

e) Medical equipment that has no change in information about types, but information about product codes has been changed because the old product codes have no longer been manufactured, in one of the following documents: valid import license or decision on grant of circulation registration number or circulation registration certificate;

g) A dossier of medical equipment circulation registration for which the Ministry of Health has previously requested in writing to supplement or issued a written refusal to grant a license, but the contents of documents are only related to the request to update the validity of one of the following documents: power of attorney of the owner of medical equipment circulation number, certificate of compliance with ISO 13485 quality management standards, and medical equipment circulation certificate;

h) A dossier of medical equipment circulation registration for which the Ministry of Health has previously requested in writing to supplement or issued a written refusal to grant a license, but the contents of documents are only required to modify or supplement the names of medical equipment.

2. Procedure for considering and giving priority in processing dossiers of registration for medical equipment circulation:

a) An applicant for priority in processing a dossier of registration for medical equipment circulation shall send to the Ministry of Health the following documents:

- A written request for priority in the processing, including sufficient information about the dossier code submitted on the portal of the Ministry of Health;

- Documents proving that it falls into the cases specified in Clause 1 of this Article;

b) The Ministry of Health shall consider and give priority in processing the dossier of registration for medical equipment circulation within 10 working days from the date of receiving a written request and enclosed documents from the applicant. In case of refusal, the Ministry of Health must issue a written response clearly stating the reasons.

3. Medical equipment in the cases specified at Point b, Clause 1 of this Article that has been granted a certificate of registration for medical equipment circulation shall not be considered for import license.

Section 4. POST-MARKET MANAGEMENT OF MEDICAL EQUIPMENT[272] AND HANDLING OF MEDICAL EQUIPMENT[273] IN SOME SPECIFIC CASES

Article 33. Requirements for dossiers of post-market management of medical equipment[274]

The circulation number holder shall establish, organize and manage the tracing of origin of medical equipment[275] on the market and fully retain dossiers of medical equipment management, including at least the following documents:

1. Dossiers for issuance of registration number for medical equipment[276], in which the following documents shall be retained in physical form:

a) The power of attorney from the owner of medical equipment[277] for the establishment performing the circulation registration, except for the cases specified at Point a, Clause 1 Article 25 of this Decree;

b) A certificate of eligibility for providing warranty services granted by the medical equipment[278] owner, unless otherwise such medical equipment is single-use medical equipment[279] as defined by the medical equipment[280] owner or there are documents proving that it is not under warranty.

c) The certificate of free sale or marketing authorization.

2. Distribution records (in cases where the circulation number holder is a representative office, it shall not be required to retain these records but must request the entity that it authorizes to import medical equipment to perform this responsibility).

3. Records of adverse events, complaints and remedial measures that indicate name, type, quantity and batch number of medical equipment[281], especially those[282] that are defective or unsafe for users.

4. A dossier of medical equipment[283] quality management, includes:

a) The certificate of origin made in accordance with law provisions on origin of goods;

b) The certificate of quality of each medical equipment[284] batch issued by the owner of medical devices or manufacturer whose name is specified in the dossier for registration of medical equipment[285];

c) Inspection results of medical equipment[286] for medical equipment[287] specified in Clause 1, Article 55 of this Decree;

d) Having technical documents serving the repair and maintenance of medical equipment[288], unless otherwise such medical equipment is single-use medical equipment[289] as defined by the medical equipment[290] owner or there are documents proving that it is not under warranty;

dd) Vietnamese use instructions of medical equipment[291];

d) Having information about the warranty service providers, and warranty conditions and duration, except disposable medical equipment[292] as specified by the owners of medical equipment[293] or unless there are documents proving that no warranty regime is applied.

Article 34. Handling of medical equipment[294] with warnings about potential risks of seriously threatening public health or possibly leading to death of users

1. In cases where a medical equipment[295] has a warning from a Vietnamese or international competent agency about a potential risk that poses a serious threat to public health or may cause death of users, the circulation number holder shall inform medical establishments using such medical equipment[296] of the warned risk and carry out investigation and identification within 30 days from the receipt of such warning. In cases where the investigation and identification takes more than 30 days, a written report clearly stating reasons and solutions for ensuring safety of users shall be submitted to the Ministry of Health.

2. In cases where the medical equipment[297] specified in Clause 1 of this Article is found to be equipment[298] that has a defect which may affect the health of users, the circulation number holder shall:

a) Suspend the circulation of the medical equipment[299] batch.

b) Send a written notice to the Ministry of Health, distributors and users of such medical equipment[300]. The notice shall clearly state the batch number and the defect which may adversely affect the health of users, and whether or not such defect can be repaired.

c) Formulate a plan for remedying or recalling the batch of defective medical equipment[301].

d) Send a report to the Ministry of Health after the remedy or recall of defective medical equipment[302] is completed.

3. In cases where the defect of medical equipment[303] can be remedied:

a) Within 03 working days from the receipt of the notice from the circulation number holder of medical equipment[304], the Ministry of Health shall be responsible for issuing a decision to suspend the circulation of the batch of defective medical equipment[305].

A suspension decision shall contain the following information:

- Name of the suspended medical equipment[306];

- Batch number of the suspended medical equipment[307];

- Circulation number of the suspended medical equipment[308].

b) After a decision on suspension of the medical equipment[309] batch is issued, the circulation number holder shall be responsible for remedying the defect, which causes adverse effects to the health of users.

c) After completing the remedy of the defect, the circulation number holder shall send a report to the Ministry of Health, accompanied by the inspection record for the medical equipment[310] specified in Clause 1, Article 55 of this Decree or commitment to maintain quality of the medical equipment[311] after the defect stated in the report has been remedied for other medical equipment[312].

d) Within 20 days from the receipt of the report on remedying the defect affecting the medical equipment[313] users sent by the circulation number owner, the Ministry of Health shall issue a decision to lift the suspension of medical equipment[314] batch circulation. In cases of refusals, the Ministry of Health shall send a written response clearly stating the reasons to the applicant.

4. In cases where the defect of medical equipment[315] cannot be remedied:

a) The Ministry of Health shall issue a decision to recall the entire batch of defective medical equipment[316].

A recall decision shall contain the following information:

- Name of the recalled medical equipment[317];

- Batch number of the recalled medical equipment[318];

- Circulation number of the recalled medical equipment[319].

b) The circulation number holder shall recall the entire batch of defective medical equipment[320] by the deadline imposed by a competent agency and bear all costs for the recall of the batch of defective medical equipment[321].

c) In cases where the circulation number holder fails to complete the recall of defective medical equipment[322] batch by the deadline imposed by the competent agency, the recall will be enforced in accordance with the law on handling of administrative violations.

Article 35. Handling of cases where medical equipment[323] has an adverse event that affects the health of users

1. In cases where a medical equipment[324] has an adverse event that pose a serious threat to public health or has caused death of a user, the circulation number holder shall assume the responsibility for:

a) Posting a notice of the adverse event on the circulation number holder’s website (if any) and send written notices of the adverse event to the Ministry of Health, traders and users of that batch of medical equipment[325];

b) Suspending the circulation of the medical equipment[326] batch involving the adverse event;

c) Conducting an investigation and verify the cause of the adverse event;

d) Sending a report to the Ministry of Health after the investigation and verification results are available. In cases where the adverse event is caused by a defect in the medical equipment[327], the report shall describe the defect and whether it can be remedied. Carrying out the remedy or recalling the batch of defective medical equipment[328], submitting a report to the Ministry of Health after completing the remedy or recall of medical equipment[329] batch.

2. In cases where the medical equipment[330]’s adverse event does not cause death but has caused serious harm to the health of users, the circulation number holder shall assume the responsibility for:

a) Sending a written notice of the adverse event to the Ministry of Health;

b) Conducting an investigation and verify the cause of the adverse event;

c) Sending a report to the Ministry of Health after the investigation and verification results are available. In cases where the adverse event is caused by a defect in the medical equipment[331], the report shall describe the defect and whether it can be remedied. Carrying out the remedy or recalling the batch of defective medical equipment[332], submitting a report to the Ministry of Health after completing the remedy or recall of medical equipment[333] batch.

3. The handling of defective medical equipment[334] that adversely affect the health of users shall comply with the provisions of Clauses 3 and 4, Article 34 of this Decree.

Article 36. Forms of handling, remedying and recalling defective medical equipment[335]

1. Forms of handling the defective medical equipment[336]:

a) Providing instructions on measures to remedy the defect;

b) Remedying the defect of medical equipment[337];

c) Replacing the defective medical equipment[338] with equivalent equipment[339];

d) Recalling the defective medical equipment for re-export or destruction;

2. Forms of recalling the defective medical equipment[340]:

a) Voluntary recall by the circulation number holder;

b) Compulsory recall in the cases specified in Article 39 of this Decree.

Article 37. Handling of medical equipment[341] in cases where the owner of medical equipment[342] or circulation number holder of the medical equipment[343] no longer carries out manufacturing or goes bankrupt or is dissolved

1. In cases where the owner of medical equipment[344] declares termination of manufacturing of medical equipment[345] which has been granted the circulation number or goes bankrupt or is dissolved, the medical equipment may continue its circulation on the market for a maximum period of 24 months from the date of the medical equipment[346] owner’s declaration of manufacturing termination, bankruptcy or dissolution provided that the circulation number holder in Vietnam provides a commitment to provide warranty or materials for replacing or serving the use of the medical equipment[347] for 08 years, unless the circulation number holder is a permanent representative office in Vietnam of a foreign trader that is the product of medical equipment[348].

2. In cases where the circulation number holder of a medical equipment[349] goes bankrupt or is dissolved, the medical equipment[350] may continue its circulation on the market for a maximum period of 24 months from the date of the medical equipment[351] circulation number holder’s declaration of bankruptcy or dissolution provided that the distributor provides a commitment to provide warranty or materials for replacing or serving the use of the medical equipment[352] for 08 years.

3. The circulation number holder or distributor shall assume the responsibility for sending their commitment to the Ministry of Health through the portal on management of medical equipment[353] within 60 days from the date on which the owner of medical equipment[354] or circulation number holder of the medical equipment[355] declares termination of manufacturing or goes bankrupt or is dissolved.

4. The commitment shall include the following documents:

a) The written commitment to provide warranty and materials serving the use of the medical equipment[356];

b) The list of medical equipment[357] with the circulation number that the applicant is holding but the owner of medical equipment[358] or circulation number holder of the medical equipment[359] declares termination of manufacturing or goes bankrupt or is dissolved.

5. Within 15 working days from the receipt of the commitment as prescribed in Clause 4 of this Article, the Ministry of Health shall send a written response indicating whether or not the medical equipment[360] may be circulated. In cases of refusals, a written response clearly stating the reasons shall be given.

6. [361] In case the Ministry of Health issues a document disallowing the continued circulation of medical equipment[362] as prescribed in Clause 5 of this Article, the circulation number holder or the distributor shall withdraw the medical equipment[363] being circulated in the market, except the medical equipment[364] which have been sold to medical establishments or users.

Section 5[365]. REVOCATION OF CIRCULATION NUMBERS OF MEDICAL EQUIPMENT[366] AND HANDLING OF MEDICAL EQUIPMENT[367] SUBJECT TO REVOCATION OF CIRCULATION NUMBERS

Article 38. Cases where circulation number is revoked

1. The applicant uses fraudulent documents to apply for registration.

2. In cases where 03 batches of the medical equipment[368] are recalled during the validity of the circulation number, except for circulation number holder’s voluntary recall of the medical equipment.

3. The applicant falsifies the contents of the circulation number without permission.

4. The circulation number holder terminates its operation or is no longer authorized by the owner of medical equipment[369] and no substitute organization has been appointed, except for the cases specified in Article 37 of this Decree.

5. Quality of the medical equipment[370] being circulated on the market is not consistent with the registered quality.

6. The circulation number has been issued against regulations on competence, dossiers and procedures specified in this Decree.

7. The circulation number holder or distributor has not provided commitment for the medical equipment[371] as prescribed in Clauses 1 and 2, Article 37 of this Decree.

8. The period for circulation of the medical equipment[372] on the market has expired as prescribed in Clauses 1 and 2, Article 37 of this Decree.

9. The medical equipment[373] have been manufactured at a factory that fails to satisfy eligibility requirements prescribed in this Decree.

10. The circulations number holder fails to comply with the provision at Point k, Clause 3, Article 74 of this Decree, except for the cases specified in Article 37 of this Decree.

11. The dossier for declaration or issuance of circulation number fails to comply with regulations of this Decree.

12. The medical equipment[374] have been classified against regulations on classification of medical equipment[375].

13. The circulation number holder voluntarily revoke the circulation number.

14. [376] The documents included in the dossier of request for registration for circulation of medical equipment[377] are concluded by a competent authority to be incompliant with the provisions of law.

Article 39. Procedures for revocation of circulation number

1. During the course of inspection, if detecting any of the cases specified in Clauses 1 through 12, Article 38 of this Decree, the agency performing the examination and inspection shall prepare and send an inspection record to the Ministry of Health or provincial-level Department of Health that has issued the circulation number (hereinafter referred to as the circulation number issuer).

2. Within 05 working days from the receipt of the inspection record specified in Clause 1 of this Article, the circulation number issuer shall consider and decide on the revocation of circulation number under their management.

3. After issuing the decision to revoke circulation number, the circulation number issuer shall assume the responsibility for:

a) Publishing the decision to revoke circulation number on its website and send it to the circulation number holder, the Ministry of Health, provincial-level Departments of Health and customs offices.

b) Removing all information related to the medical equipment[378] published on its website.

4. When receiving the circulation number issuer's decision to revoke circulation number, provincial-level Departments of Health shall publish the full text of the decision on their websites and direct specialized agencies to supervise the recall of relevant medical equipment[379].

5. In cases of voluntarily applying for revocation of circulation number, the circulation number holder shall submit an application clearly stating the reasons for such revocation to the circulation number issuer. After receiving the application, the circulation number issuer shall carry out the procedures for revocation of circulation number as prescribed in Clauses 2 and 3 of this Article.

6. [380] Within 5 working days after receiving a conclusion from a competent authority in the case specified in Clause 14, Article 38 of this Decree, the agency having granted the circulation number shall consider and issue a document to revoke the circulation number under its management.

After the document on revocation of the circulation number is issued, related competent agencies shall carry out the procedures specified in Clauses 3 and 4 of this Article.

Article 39a. Handling of medical equipment[381] after their circulation numbers are revoked [382]

1. Medical equipment[383] which have been sold to medical establishments or users may continue to be used until they are liquidated in accordance with law or until their shelf life expires, except medical equipment[3841] of which the faults that adversely affect the users’ health cannot be remedied as specified in Clause 4, Article 34 of this Decree.

2. In case the medical equipment[385] which have their circulation number revoked have not been sold to users or medical establishments, the circulation number holders shall discontinue the circulation of the medical equipment[386] and take measures to withdraw medical equipment[387].

Chapter VI

MANAGEMENT OF TRADING OF MEDICAL EQUIPMENT[388]

Section 1. REQUIREMENTS FOR TRADING MEDICAL EQUIPMENT[389]

Article 40. Requirements for type-B, C or D medical equipment[390] trading establishments

1. Having at least 01 technical staff with an associate degree, or higher, in technology, medicine, pharmacy, chemistry, biology or medical devices, or an associate degree, or higher, suitable for the medical equipment[391] which the establishment trades.

2. Having warehouse and vehicles for transporting medical devices that satisfy the following minimum requirements:

a) The warehouse must:

- Have an area suitable for the types and quantities of stored medical equipment[392];

- Be well ventilated, dry and clean, and separated from sources of pollution;

- Meet other storage requirements for the medical equipment[393] in accordance with their use instructions.

b) The vehicles for transporting medical equipment[394] from trading establishments to buyers must be suitable for types of such medical equipment[395];

In cases where a trading establishment that does not have a warehouse or vehicle for transporting medical equipment[396], the trading establishment may sign a contract with a qualified unit for storage and transport of medical equipment[397].

3. With regard to an establishment trading in medical equipment[398] containing narcotics and precursors:

a) The person in charge of expertise must have a bachelor’s degree in medical equipment[399], medicine, pharmacy, pharmaceutical chemistry or biology.

b) The trading establishment must have a warehouse that satisfies the requirements as prescribed in Article 7 of the Government’s Decree No. 80/2001/ND-CP dated November 05, 2001, guiding the control of lawful drug-related activities in the country.

c) There is a system to monitor and manage the export, import and inventory of medical equipment[400] containing narcotics and precursors.

Article 41. Dossiers and procedures for declaration of eligibility for medical equipment[401] trading

1. An application dossier for declaration of eligibility for manufacture of medical equipment[402] shall be prepared as 01 set, including:

a) A written declaration of eligibility for medical equipment[403] trading;

b) A personnel list;

c) Documents proving that the warehouse and vehicle for transporting medical equipment[404] satisfy the requirements specified in Clause 2, Article 40 of this Decree. These documents must be certified by the applicant;

d) Documents proving that the warehouse and the system to monitor and manage the export, import and inventory of medical equipment[405] containing narcotics and precursors comply with the requirements as prescribed in Clause 3, Article 40 of this Decree. These documents must be certified by the establishment making declaration of eligibility for trading in medical equipment[406] that contain narcotics and precursors.

2. Procedures for declaration of eligibility for medical equipment trading:

a) Before trading medical equipment[407], the trading establishment shall assume the responsibility for submitting a dossier for declaration of eligibility for medical equipment[408] trading to the Department of Health of province where the trading establishment is located.

b) After receiving the application dossier (including the receipt of application fee as prescribed by the Ministry of Finance), the provincial-level Department of Health where the medical equipment[409] trading establishment is located shall publish on the Portal on Management of Medical Equipment [410] all information about such application dossier for declaration of eligibility for trading medical equipment[411].

c) During its operation, the trading establishment shall prepare a notice of changes enclosed with documents related to such changes and update such documents to its application dossier for declaration published on Portal on Management of Medical Equipment [412] within 03 working days from the occurrence of such changes.

Article 42. Trading in medical equipment[413] which is not required to satisfy requirements nor follow procedures for declaration of eligibility for trading

1. Type B, C or D medical equipment[414] included in the list of medical equipment[415] issued by the Minister of Health shall be traded like other normal goods.

2. The trade of medical equipment[416] specified in Clause 1 of this Article is not required to satisfy requirements as prescribed in Article 40 of this Decree and is not required to follow the procedures for declaration of eligibility for medical equipment trading as prescribed in Article 41 of this Decree, provided that such trading is conformable to the requirements for storage and transport prescribed by the owner of medical equipment[417].

Section 2. MANAGEMENT OF MEDICAL EQUIPMENT[418] PRICE

Article 43. Principle for state management of medical equipment[419] prices

1. Managing prices of medical equipment[420] according to the market mechanism; respecting the right to pricing and price competition of entities trading in medical equipment[421] in accordance with law provisions.

2. Ensuring the publicity and transparency of medical equipment[422] prices during the circulation on the market.

3. Protecting the lawful rights and interests of medical equipment traders and users, and of the State.

4. Taking measures for ensuring management of medical equipment[423] prices suitable to socio-economic development conditions in each period.

Article 44. Listing of prices of medical equipment[424] [425]

1. Manufacturers and traders of medical equipment[426] shall list prices of the medical equipment[427] at the places specified in Article 17 of the Government’s Decree No. 177/2013/ND-CP of November 14, 2013, detailing and guiding the implementation of a number of articles of the Law on Price or on the Ministry of Health’s Portal.

2. In case of listing the price of a medical equipment[428] on the Portal of the Ministry of Health, at least the following information is required:

a) Name and type of medical equipment[429];

b) Manufacturer, country of manufacture; owner, country of the owner;

c) Unit of calculation;

d) Configuration and technical features of the medical equipment[430];

dd) Listed price of the medical equipment[431].

Article 45. Declaration of prices of medical equipment[432] [433]

1. Manufacturers and traders of medical equipment shall declare prices of the medical equipment; contents, and order and procedures for declaration of prices of medical equipment[434] must comply with the law on price.

2. When there is an abnormal fluctuation in prices affecting the supply of medical equipment[435], affordability of buyers, and solvency of the Health Insurance Fund, the Minister of Health shall, based on the actual situation, issue, update, amend and supplement the list of medical equipment subject to price declaration and guide the provision of information on these medical equipment[436].

3. Manufacturers and traders of medical equipment[437] shall declare prices of the medical equipment[438] in the forms specified in the law on price or on the Portal of the Ministry of Health.

Section 3. EXPORT AND IMPORT OF MEDICAL EQUIPMENT[439]

Article 46. Principles of management of import and export of medical equipment[440] [441]

1. Medical equipment[442] importers and exporters must satisfy the conditions specified in the law on import and export and shall be held responsible for the quality, quantity, categories and use purposes of medical equipment[443] they import or export.

2. Medical equipment[444] that have been granted circulation numbers in Vietnam may be imported or exported without being subject to any quantity limitations and having to obtain approval from the Ministry of Health.

3. An import license is required for medical equipment[445] falling into the cases specified in Clause 1, Article 48 of this Decree, when imported for use in Vietnam.

4. Medical equipment[446] that do not fall into the cases specified in Clauses 2 and 3 of this Article, when brought into Vietnam by other modes, must comply with the law on foreign trade management.

5. The issuance of the certificate of free sale for medical equipment[447] must comply with the law on foreign trade management.

6. The import of used medical equipment[448] shall comply with the law on foreign trade management.

Article 47. Export and import of medical equipment[449]

1. Domestic enterprises are encouraged to manufacture medical equipment for export.

2. An organization or individual wishing to import the medical equipment[450] that has been granted circulation number shall satisfy the following conditions:

a) Being the circulation number holder or having the power of attorney of the circulation number holder. When authorizing import of medical equipment[451], the circulation number holder shall send a copy of the power of attorney to the circulation number issuer and the customs office;

b) Having a warehouse and vehicles for transporting medical equipment that satisfy the requirements prescribed in Clause 2, Article 40 of this Decree or having entered into a contract with a qualified medical equipment[452] storage and transport service provider;

c) Having a warehouse and system to monitor and manage the export, import and inventory of medical equipment[453] containing narcotics and precursors that meet the requirements prescribed in Clause 3 Article 40 of this Decree.

3. Procedures for import and export of medical equipment[454] shall comply with the law on customs. Importers of medical equipment[455] shall not be required to prove their satisfaction of the requirements laid down in Clause 2 of this Article when following customs procedures.

Article 48. Import license

1. An import license is required in the following cases:

a) Medical equipment[456] does not have the circulation number and is imported to serve scientific research, testing, inspection, experiment, performance evaluation, or instruction for use or medical equipment[457] modification only;

b) Medical equipment[458] does not have the circulation number and is imported to serve disease prevention and control, or disaster recovery;

c) Medical equipment[459] does not have the circulation number and is imported as assistance or humanitarian aid; gifts or presents given to medical establishments; or to serve display at trade fair, exhibition or product launch event;

d) Medical equipment[460] does not have the circulation number and is imported to serve charitable medical examination and treatment;

dd) Medical equipment[461] does not have the circulation number and is imported for personal treatment of illness, including personalized medical equipment[462], or to serve a medical establishment’s special diagnosis demand;

e) [463] Medical equipment[464] without circulation numbers which are imported for use at medical establishments and purchased from the sources of official development assistance (ODA), concessional loans, or non-refundable aid other than ODA.

2. An application dossier for import license shall include:

a) A written request for import license;

b) A synopsis of the technical description of medical equipment[465] in Vietnamese;

c) The certificate of conformity with quality control standards of the medical equipment[466] manufacturer bearing the applicant’s certification;

d) In cases where medical equipment is imported to serve research: a certified true copy of the decision to approve the research and documents bearing the applicant’s certification proving that the medical equipment[467] has been granted marketing authorization by a competent agency;

dd) In cases where medical devices are imported to serve training purposes: the original copy of the training program and documents bearing the applicant’s certification proving that the medical equipment[468] has been granted marketing authorization by a competent agency;

e) In cases where medical equipment is imported to serve testing, inspection, experiment, or performance evaluation: the certification indicating the quantity of the imported devices given by the agency competent to carry out such testing, inspection, experiment, or performance evaluation;

g) In cases where medical equipment is imported as aid: a copy of the decision to approve the aid and documents bearing the applicant’s certification proving that the medical equipment[469] has been granted marketing authorization by a competent agency;

h) In cases where medical equipment is imported as gift or present given to a medical establishment: the original copy of the training program and documents bearing the applicant’s certification proving that the medical equipment[470] has been granted marketing authorization by a competent agency;

i) In cases where medical equipment is imported to serve charitable medical examination and treatment: documents bearing the applicant’s certification proving that the medical equipment[471] has been granted marketing authorization by a competent agency;

k) In cases where medical equipment is imported to serve a medical establishment’s special diagnosis demand: documents bearing the applicant’s certification proving that the medical equipment[472] has been granted marketing authorization by a competent agency;

l) In cases where medical equipment is imported to serve personal treatment of illness, including personalized medical equipment[473]: a copy of the physician’s prescription which is consistent with the applicant’s illness;

m) In cases where medical equipment is imported to serve a trade fair, exhibition, display or product launch event: copies of documents on the program, invitation letter and service contract;

n) In cases where medical equipment imported to serve the purposes of disease prevention and control or disaster recovery, the following documents are required:

- A written approval by a competent agency for urgent needs in disease prevention and control, and remediation of consequences of natural disasters or catastrophes;

- Documents bearing the applicant’s certification proving that the medical equipment[474] has been granted marketing authorization or license for emergency use by a competent agency.

o) [475] For cases of import specified at Point e, Clause 1 of this Article, a dossier of  application for an import license must also comprise the following documents:

- The original or a certified copy of the decision approving the investment policy and the investment decision, for investment projects, or the decision approving project documents, for technical assistance projects, project costs or non-refundable aid other than ODA, clearly stating the content on import of medical equipment[476];

- The original or a certified copy of the contract on supply of medical equipment[477] to the projects;

- The power of attorney made by the owner of the medical equipment[478] to the import license applicant which must remain valid at the time of dossier submission: to submit a consularly legalized copy or a certified copy of the consularly legalized copy;

- A certificate of eligibility for providing warranty services granted by the medical equipment[479] owner, unless otherwise such medical equipment is single-use medical equipment[480] as defined by the medical equipment[481] owner or there are documents proving that it is not under warranty. A consularly legalized copy or a certified copy of the consularly legalized copy is required;

- A CFS, which remains valid when the dossier is submitted, for an imported medical equipment[482]. to submit the consularly legalized copy or a certified copy of the consularly legalized copy. In cases where the marketing authorization is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified in accordance with law provisions.

3. Procedures for processing an application dossier for license to import medical equipment[483]:

a) In cases where the dossier for an import license of medical equipment[484] does not need to be modified or supplemented, the Ministry of Health shall assume the responsibility for: appraising such dossier to issue the import license within 15 working days, or 02 working days for an unregistered medical equipment[485] that is imported to serve disease prevention and control or disaster recovery, from the receipt of the complete and valid dossier (including fee receipts for appraisal and issuance of import license as prescribed by the Ministry of Finance). In cases of refusal, a written response clearly stating the reasons for such refusal is required.

The import license shall be sent to the applicant and customs offices.

b) In cases where the dossier for grant of medical equipment[486] import license is not complete, the Ministry of Health shall send a request for supplementing and amending the dossier, in which such documents and contents requiring modification must be specified, to the applicant for medical equipment[487] import license within 10 days, or 02 working days for a medical equipment[488] without import circulation number that is imported to serve disease prevention and control or disaster recovery, from the receipt of the complete and valid dossier.

c) When receiving a request for supplementing or amending the dossier, the applicant must supplement or amend the dossier as notified and send it to the Ministry of Health.

In cases where the applicant has supplemented or amended the dossier but it fails to comply with the request, the Ministry of Health shall send the applicant a request for continuing to complete the dossier as prescribed.

d) In cases where the applicant fails to provide the modified dossier within 30 days from the receipt of the Ministry of Health’s request for modification, the applicant shall re-carry out procedure for import.

dd) In cases where the modified dossier is satisfactory, the Ministry of Health shall issue an import license in accordance with Point a of this Clause. The import license shall be sent to the applicant and customs offices.

Article 49. Application dossiers for Certificate of Free Sale for medical equipment[489]

1. An application dossiers for Certificate of Free Sale for medical equipment[490]:

a) A written request for certificate of free sale.

b) A certified true copy of the certificate of conformity with quality control standards issued by a conformity assessment agency as prescribed by law, which remains valid at the time of application submission.

2. Procedures for issuing a certificate of free sale shall comply with the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018, detailing a number of articles of the Law on Foreign Trade Management.

Article 50. Competence and procedures for issuance, re-issuance and revocation of Certificate of Free Sale

1. The Minister of Health shall assume the responsibility for the issuance, re-issuance and revocation of certificate of free sale for medical equipment[491].

2. Procedures for the issuance, re-issuance and revocation of certificate of free sale shall comply with the Prime Minister’s regulations on issuance of certificate of free sale.

Section 4. RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS ENGAGED IN TRADING OF MEDICAL EQUIPMENT[492]

Article 51. Rights of medical equipment[493] trading establishments

1. Requesting the medical equipment[494] seller to provide adequate information and documents serving the tracing of origin and warranty on the medical equipment[495].

2. Requesting importers, distributors and users to cooperate in recalling and handling defective medical equipment[496].

3. Requesting the medical equipment[497] circulation number holder or warranty establishment that is recognized by the owner of medical equipment[498] to provide warranty on the medical equipment[499].

4. Being notified by the circulation number holder about defective medical equipment[500].

5. Exercising other rights as prescribed by law provisions.

Article 52. Obligations of medical equipment[501] trading establishments

1. Implementing internal control measures to maintain the quality of medical equipment[502] as prescribed by the circulation number holder.

2. Providing users with adequate and timely information about:

a) Instructions for use of medical equipment[503]; conditions for ensuring safety, storage, calibration, inspection and maintenance of medical equipment[504];

b) Notices of defective medical equipment[505].

3. [506] Listing and declaring prices of medical equipment[507] in accordance with this Decree and the law on price.

4. Retaining records of medical equipment[508] monitoring and carrying out tracing of origin and recall of medical equipment[509] in accordance with the provisions of this Decree.

5. Promptly notifying circulation number holders and state management agencies of defective medical equipment[510].

6. Complying with regulations of law and inspection decisions issued by competent agencies.

7. Performing other obligations as prescribed by law.

Chapter VII

MEDICAL EQUIPMENT-RELATED SERVICES [511]

Section 1. MEDICAL EQUIPMENT[512] TECHNICAL CONSULTING

Article 53. Conditions for providing medical equipment[513] technical consulting

1. The provision of services for consulting on listing and formulation of technical configuration and functions of medical equipment[514] must be conducted by individuals who have certificates of completion of training course in technical consulting on medical devices.

2. An individual who provides medical device technical consulting must satisfy the following conditions:

a) Having a bachelor’s degree, or higher, in technology, medicine or pharmacy;

b) Having at least 05 years’ experience of working in medical equipment[515] technology in medical establishments;

c) Having been examined and recognized by the training institution to be capable of providing medical equipment[516] technical consulting according to the training program issued by the Ministry of Health.

3. A consultant shall only provide medical device technical consulting after the Ministry of Health publishes his/her information and dossier for declaration of eligibility to provide medical device technical consulting as prescribed at Point b, Clause 2, Article 54 of this Decree.

Article 54. Dossiers and procedures for declaration of eligibility to provide medical device technical consulting

1. An application dossier for declaration of eligibility to provide medical device technical consulting shall include:

a) A written request for declaration of eligibility to provide medical device technical consulting;

b) Certified true copies of qualifications/certificates as prescribed at Points a and c, Clause 2, Article 53 of this Decree;

c) A certificate of working time.

2. Procedures for declaration of eligibility to provide medical device technical consulting:

a) Before providing medical device technical consulting, the applicant shall assume the responsibility for submitting an application dossier for declaration of eligibility to provide medical device technical consulting to the Ministry of Health.

b) After receiving the dossier (including fee receipts as prescribed by the Ministry of Finance), the Ministry of Health shall publish on the portal on management of medical equipment[517] all information about and dossier for declaration of eligibility to provide medical equipment[518] technical consulting.

c) During its operation, the consultant shall assume the responsibility for making a written notice of changes which is accompanied by supporting documents for such changes, and updating such documents to his/her declaration dossier published on the portal on management of medical equipment[519] within 03 days from the occurrence of such changes.

Section 2. INSPECTION AND CALIBRATION OF MEDICAL EQUIPMENT[520]

Article 55. Principle for the inspection and calibration of medical equipment[521]

1. Medical equipment[522] on the list announced by the Minister of Health must undergo safety and function inspection before use (except for the cases prescribed in Article 57 of this Decree), periodically and after major overhaul. The inspection of medical equipment[523] being measurement devices and radiological devices shall be carried out in accordance with regulations in Clause 2 of this Article.

2. Medical equipment[524] that are measurement devices and radiological devices must undergo inspection and calibration in accordance with law regulations on measurement and atomic energy.

Article 56. Requirements for the provision of medical equipment[525] inspection services

Requirements in terms of devices, personnel; the application dossier for the Certificate; the form of submitting the dossier; the procedure for issuing, revising, reissuing and revoking the Certificate of registration of medical equipment[526] inspection services shall be carried out in accordance with current law regulations on conformity assessment services;

Of which, the satisfaction of professional requirements for medical equipment[527] inspection shall be prescribed as follows:  each inspection process registered by an inspecting organization must be handled by at least 02 inspectors who have certificates of training in such inspection process.

Article 57. Exemption of first inspection before use for medical equipment[528]

Medical equipment[529] shall be eligible for the exemption of first inspection before use in one of the following cases:

1. The medical equipment[530] already has the Certificate of conformity.

2. The unregistered medical equipment[531] is imported to serve scientific research or training in use, maintenance or repair of such equipment[532].

3. The unregistered medical equipment[533] is imported for the importer’s personal treatment or charitable medical examination and treatment or serving special diagnostic purposes.

4. The medical equipment[534] yet granted an circulation number that is imported for display at an exhibition or introduction event.

Article 58. Handling of unqualified medical equipment[535]

1. In cases where the result of inspection before use of medical equipment[536] is not satisfactory:

a) Health facilities must not receive or use the medical equipment[537];

b) The inspecting organization shall send a notice of the unsatisfactory result to the Ministry of Health;

c) If 03 medical equipment[538] in the same batch fail the safety and function inspection, the Ministry of Health shall request the circulation registration number holder to send a written report on the quantity of medical devices being sold on the market and being used by health facilities;

Based on the report of the holder and the unsatisfactory result, the Ministry of Health shall decide on the re-inspection, the quantity of specimens that must undergo re-inspection, or suspend the use of such medical equipment[539].

Based on the re-inspection result, the Ministry of Health shall decide on the implementation of another re-inspection, the quantity of specimens that must undergo another re-inspection, or request the circulation registration number holder to recall the whole batch of medical equipment[540].

In cases where 03 batches of medical equipment[541] are revoked during the effective period of the circulation number, the circulation number of such medical equipment[542] will be revoked. Medical equipment[543] that has been used by health facilities before the issuance of the decision on the revocation of such circulation number may continue to be used if they satisfy the inspection requirements.

2. In the cases where the result of a periodic inspection or post-overhaul inspection of the medical equipment[544] is not satisfactory:

a) Health facilities must not continue using the medical equipment[545];

b) The marking of the previous inspection result shall be removed;

c) Health facilities shall cooperate with the circulation number holder in implementing corrective measures and carrying out a re-inspection;

d) Medical devices shall only be used if the re-inspection result is satisfactory.

Chapter VIII

MANAGEMENT OF RAW MATERIALS FOR MANUFACTURE OF MEDICAL EQUIPMENT[546], SUBSTANCES FOR EXTERNAL QUALITY ASSESSMENT THAT CONTAIN NARCOTIC SUBSTANCES AND PRECURSORS

Article 59. Principle for management of raw materials for manufacture of medical equipment[547], substances for external quality assessment that contain narcotic substances and precursors

1. The concentration and content of raw materials for manufacture of medical equipment[548], substances for external quality assessment that contain narcotic substances and precursors must be declared before they are imported to or exported from Vietnam.

2. The customs clearance must be in accordance with the declaration number and shall not require the import license issued by the Ministry of Health.

Article 60. Application dossiers and procedures for the declaration of raw materials for manufacture of medical equipment[549], substances for external quality assessment that contain narcotic substances and precursors

1. The application dossier for declaration shall include:

a) The written declaration of raw materials for manufacture of medical equipment[550], substances for external quality assessment that contain narcotic substances and precursors;

b) The Certificate of conformity with quality control standards;

c) Technical documents.

2. Procedures for the declaration of concentration, content of narcotic substances and precursors:

a) Before importing raw materials for manufacture of medical equipment[551] and substances for external quality assessment that contain narcotic substances and precursors, the importer shall be required to publish the full and valid application dossier for declaration as prescribed in Clause 1 of this Article on the Portal on the management of medical equipment[552];

b) After receiving a complete and valid application dossier, the Ministry of Health shall publish on the Portal on the management of medical equipment[553] all information and the application dossier for declaration of raw materials for manufacture of medical equipment[554] and substances for external quality assessment that contain narcotic substances and precursors.

3. Importers/exporters shall be responsible for reapplying for the declaration of concentration/content of narcotic substances and precursors whenever there are any changes to their declaration dossiers.

Chapter IX

INFORMATION ON MEDICAL EQUIPMENT[555]

Article 61. Information on medical equipment[556]

1. Information about medical equipment[557] shall be for the purpose of providing healthcare staff and users of medical equipment[558] with guidelines on the reasonable and safe use of medical equipment[559].

2. Information about medical equipment[560] must be sufficient, objective, accurate, honest, understandable and must not cause any misunderstanding.

3. Responsibility to provide information on medical equipment[561] shall be prescribed as follows:

a) The circulation number holders and medical equipment[562] trading establishments shall be responsible for publishing information on the levels of risks and other information related to the use of medical equipment[563];

b) Health facilities shall be responsible for internally disseminating information on medical equipment[564];

c) Healthcare staff shall be responsible for disseminating information on the levels of risks of the use of Class-C, D medical equipment[565] to patients;

d) Management agencies in charge of medical equipment[566] shall be responsible for making information on medical equipment[567] publicly available.

4. Organizations and individuals providing information on medical equipment[568] shall assume the responsibility for their provided information.

5. The Minister of Health shall be responsible for organizing an information system on medical equipment[569].

Article 62. Advertising medical equipment[570]

1. Contents of an advertisement for a medical equipment[571] must be consistent with one of the following documents:

a) An application dossier for declaration of applicable standards of Type-A or Type-B medical equipment[572];

b) An application dossier for circulation registration number of Class-C or Class-D medical equipment[573].

2. An advertisement for a medical equipment[574] must include the following information:

a) The name, category, product code, manufacturer and manufacturing country of the medical equipment[575];

b) The circulation number;

c) The functions and uses;

d) The name and address of the medical equipment[576] circulation number holder or the organization authorized by the medical equipment[577] circulation number holder;

dd) Health warnings for users and storage conditions (if any).

3. Audio or video advertisement on medical equipment[578] must display clearly information specified in Clause 2 of this Article.

4. Before carrying out the advertising, the medical equipment[579] circulation number holder or the organization authorized in writing by the medical equipment[580] circulation number holder shall be responsible for publishing planned contents and form of advertising on the Portal on the management of medical equipment[581].

5. The medical equipment[582] circulation number holder or the organization authorized by the medical equipment[583] circulation number holder shall take responsibility before law for the conformity of advertisement contents with the planned advertisement contents having been published and the application dossier for declaration of applied standards of Class-A or Class-B medical equipment[584] or the application for registration of Class-C or Class-D medical equipment[585].

6. Documents or materials that do not mention the name of medical equipment[586]; those that contain only name and technical specifications of the medical equipment[587] without information on the functions or uses; scientific research documents; clinical documents; documents used for training in use of products shall not be considered as advertising documents.

Chapter X

MANAGEMENT AND USE OF MEDICAL EQUIPMENT[588] AT MEDICAL ESTABLISHMENTS

Article 63. Principles of management and use of medical equipment[589]

1. The management and use of medical equipment[590] must be conformable with the purposes, utilities, policies, economical and effective.

2. Medical equipment[591] must be inspected, maintained, repaired, used and must comply with other manufacturer's technical instructions and undergo inspection in accordance with regulations of this Decree to ensure quality.

For medical equipment[592] subject to strict occupational safety and health requirements, such devices must comply with regulations on quality control specified in this Decree and law regulations on occupational safety and health.

3. Dossiers on medical equipment[593] shall be compiled, managed and retained sufficiently; the settlement of medical equipment[594] in physical form or in value shall be conducted in accordance with current law on accounting and statistics and other relevant laws; the funding for the performance of tasks specified in Clause 2 of this Article shall be ensured.

4. To undergo the inspection, monitoring and supervision of competent agencies in charge of managing medical equipment[595].

Article 64. Management and use of medical equipment[596] in State-owned medical establishments

State-owned medical establishments, apart from complying with the law on management and use of medical equipment[597] specified in Article 63 of this Decree, shall manage medical equipment[598] in accordance with the following provisions:

1. Investment in, purchase, management and use of medical equipment[599] shall comply with law regulations on management and use of public assets.

2. The use of domestically manufactured medical equipment[600] shall be encouraged.

Article 65. Rights and responsibilities of medical establishments for management and use of medical equipment[601]

1. Medical establishments shall have the following rights:

a) To request the circulation number holder or the warranty center recognized by the medical equipment[602] owner to provide periodical maintenance during the warranty period;

b) To request the seller to provide technical documents of such medical equipment[603];

c) To receive the used medical equipment[604] to serve their scientific research and training in use and repair of medical equipment[605].

2. Medical establishments shall be responsible for:

a) Using and operating the medical equipment[606] in accordance with the instructions of the medical equipment[607] owner;

b) Carrying out periodical maintenance, inspection and calibration in accordance with the instructions of the medical equipment[608] owner or as prescribed by the law;

c) Participating in testing for and assessment of quality of medical equipment[609];

d) Reporting on cases of defective medical equipment[610] and other information at the request of competent State agencies.

Chapter XI

ONLINE DECLARATION AND REGISTRATION

Article 66. Procedures to be conducted online

1. Declaration of eligibility for manufacture of medical equipment[611].

2. Declaration of applied standards for medical equipment[612].

3. Application for circulation registration of medical equipment[613].

4. Declaration of eligibility for medical equipment[614] trading.

5. Declaration of eligibility to provide medical equipment[615] technical consulting.

6. Application for the Certificate of registration of medical equipment[616] inspection services.

7. Application for the License to import medical equipment[617].

8. Application for the Certificate of free sale for domestically manufactured medical equipment[618].

9. Declaration of prices of medical equipment[619].

10. Declaration of concentration, content of raw materials for manufacture of medical equipment[620] and substances for external quality assessment that contain narcotic substances and precursors.

11. Declaration of contents and form of advertising of medical equipment[621].

12. [622] If the dossier of application for a license specified in this Decree contains a classified document as prescribed by law, such classified document shall be submitted by the mode of hand-delivery and stored according to the regime applicable to classified documents.

Article 67. Requirements for online application dossiers

The application dossiers for declaration, registration, and issuance of the Certificate of free sale (hereinafter referred to as online application dossiers) shall be considered valid when meeting the following requirements:

1. Having sufficient documents and content of those documents is fully declared in accordance with the regulations as a paper document and converted into electronic form. Name of electronic file must be must be corresponding to the name of such document type in the paper file.

2. Information on the declaration, registration and application for license must be compiled adequately and accurately in electronic documents.

Article 68. Procedures for online declaration

1. The legal representatives or their authorized persons shall declare information, upload electronic documents, make confirmation using digital signature (if any) and make online application fee payment in accordance with the prescribed procedures on the Portal on the management of medical equipment[623].

2. The agencies in charge of receiving online application dossiers shall carry out administrative procedures relevant to the application dossiers in accordance with regulations of this Decree.

3. The results of online administrative procedures shall have the same legal effect as those of normal administrative procedures.

Article 69. Storage of online application dossiers

1. In cases of conducting online registration, the applying establishment shall be required to store physical documents of such application dossier in accordance with Clause 1 Article 33 of this Decree.

2. In cases where any physical documents included in the application dossier specified in Clause 1 of this Article is lost or damaged, the applying establishment shall be responsible for sending a written notice to the receiving agency, repreparing the dossier, sending a written notice to the receiving agency on the completion of such dossier, and updating the dossier after getting the approval from the receiving agency.

3. Within 35 days from the date on which the written notice on the loss of the dossier is received, if the applying organization fails to send a written notice on their completion of the dossier, the receiving agency shall be responsible for:

a) Removing all information published on the Portal about the medical equipment[624] manufacturer, medical equipment[625] trading establishment or medical equipment[626] technical consultant, raw materials for manufacture of medical equipment[627], substances for external quality assessment that contain narcotic substances and precursors, medical equipment[628] inspection service provider, and circulation number of the medical devices;

b) Revoking the circulation number and License to import medical equipment[629].

4. The applying establishment shall not be allowed to continue their operation and medical equipment[630] shall not be allowed to be circulated from the date on which the receiving agency removes information in accordance with regulations in Clause 3 of this Article.

Chapter XII

IMPLEMENTATION ORGANIZATION

Article 70. Responsibilities of the Ministry of Health

The Ministry of Health shall assume the responsibility before the Government for state management on medical equipment[631] and shall have the following tasks and powers:

1. To submit to the Government or Prime Minister to promulgate, or promulgate within their jurisdiction legal documents, national technical regulations, strategies, policies and plans on medical equipment[632].

2. To direct and organize the implementation of legal documents, national technical regulations, strategies, policies and plans on medical equipment[633].

3. To organize information dissemination and communication on medical equipment[634].

4. To provide training for human resources in the field of medical equipment[635].

5. [636] To publish on the Ministry of Health’s Portal information about:

a) The winning bids of medical equipment[637] procurement packages of state-run medical establishments nationwide;

b) The list of medical equipment[638] of which circulation numbers have been revoked;

c) The list of organizations and individuals that have forged dossiers or violated this Decree’s provisions on management of medical equipment[639].

6. To decide on the application or exemption of provisions of this Decree to products or goods which are considered as medical equipment[640] in some countries but may not be considered as such[641] in other countries.

7. [642] To assume the prime responsibility for, and coordinate with state management agencies in, inspecting, examining, settling complaints and denunciations, and handling violations of law in the field of medical equipment[643] in accordance with law and this Decree.

8. To update and publish the list of organizations specified at Point a, Clause 2, Article 29 of this Decree.

9. To provide detailed regulations on classification of medical equipment[644] which must be conformable with ASEAN’s treaties on the classification of medical equipment[645] to which Vietnam is a signatory; to issue practical training programs on the classification of medical equipment[646].

10. To issue the list of medical equipment[647] subject to inspection and class-based inspection procedures for listed medical equipment[648].

11. To provide guidelines for the common submission dossier template on medical equipment[649] in accordance with ASEAN’s regulations.

12. To provide specific provisions on the forms providing details on the implementation of this Decree.

13. [650] To publish and modify the list of medical equipment[651] subject to price declaration according to management requirements and actual situation.

14. [652] To issue instructions on provision of information of medical equipment[653] subject to price declaration.

Article 71. Responsibility of the Ministry of Science and Technology

1. To promulgate the list of medical equipment[654] being measuring devices subject to sample approval, inspection and calibration after obtaining the consent from the Ministry of Health.

2. To assume the prime responsibility and cooperate with the Ministry of Health in developing the national standards on medical equipment[655]; quality inspection of medical equipment[656] being measuring devices and radiation devices.

Article 72. Responsibility of the Ministry of Finance

1. To provide guidelines for the management of public assets that are medical equipment[657] for State-owned health establishments after obtaining opinions from the Ministry of Health.

2. To provide specific provisions on the management and use of fees and charges in the field of medical equipment[658] in accordance with law regulations on fees and charges.

3. To carry out examination, inspection and take sanctions against violations in the field of medical equipment[659].

Article 73. Responsibility of provincial-level People’s Committees

1. To assume responsibility to manage activities related to trading and use of medical equipment[660] in their locality.

2. To organize information dissemination and communication on medical equipment[661] in their locality.

3. To provide training for human resources in the field of medical equipment[662] in their locality.

4. To publish on the Portal of the provincial-level People's Committee and send to the Ministry of Health the following information:

a) The winning bids of medical equipment[663] procurement packages of state-run medical establishments nationwide;

b) List of medical equipment[664] whose circulation number has been revoked in their locality

5. [665] To be responsible for organizing and implementing the procedures as prescribed in this Decree; to organize the inspection and examination, settle complaints and denunciations and handle violations of law in the field of medical equipment[666] and in the field of price for medical equipment[667] occurring in the provincial-level locality in accordance with law.

Article 74. Responsibility of organizations and individuals trading in medical equipment[668]

1. Organizations and individuals trading in medical equipment[669] must take responsibility for the safety and quality for the medical equipment[670] they trade.

2. Domestic medical equipment[671] manufacturers shall take responsibility to manage quality of medical equipment[672] during manufacture, transportation and storage process of medical equipment[673] in accordance with their application dossiers for circulation number.

3. Circulation number holders shall take responsibility:

a) To carry out classification of medical equipment[674], publish on the Ministry of Health’s Portal and take responsibility before law for their classification results;

To take remedial measures for incorrect classification results that reduce the level of risks of classified medical equipment[675] or incorrect classification results in term of competence specified in this Decree.

b) To conduct the declaration of applied standards or application for registration of medical equipment[676] in accordance with this Decree. To take responsibility before law for the accuracy and truthfulness of their application dossiers for circulation number;

c) To establish and maintain operation of warranty centers for medical equipment[677] or sign service contracts with medical equipment[678] warranty service providers, except for cases of disposable medical equipment[679] as defined by medical equipment[680] owners or cases where there are documents proving that the medical equipment is not under warranty;

d) To prepare and maintain documents on the management of medical equipment[681] and carry out the tracing of origin of medical equipment[682] as prescribed in this Decree, except for cases of disposable medical equipment[683] as defined by medical equipment[684] owners; to report to the Public Security force upon the loss of medical devices or raw materials for manufacture of medical devices that contain narcotic substances and precursors;

dd) To provide adequate and accurate information about the product on the label and use instructions of the medical equipment[685] in accordance with law regulations on goods labels and law regulations of this Decree;

e) To issue prompt, adequate and accurate warnings about the risks to users’ health and the environment; preventative measures for sellers and users to minimize the risks; provide information about requirements for transportation, storage and use of medical equipment[686];

g) To promptly suspend the circulation, notify relevant parties and take handling and remedial actions or recall defective medical equipment[687] in accordance with law regulations of this Decree. In cases of handling by destruction of defective medical equipment[688], the destruction shall comply with law regulations on environmental protection and relevant law regulations and the circulation number holders shall bear all the destruction costs;

h) To comply with law regulations and decisions on the inspection and examination issued by competent State management agencies;

i) To pay compensation for damage caused by defective medical equipment[689] as prescribed by the law;

k) To ensure that the following documents are effective during the effective period of the circulation number:

- The Certificate of free sale (for imported medical equipment[690]);

- The power of attorney, except the case specified at Point a, Clause 1 Article 25 of this Decree;

- The Certificate of eligibility to provide warranty services, except for cases of disposable medical equipment[691] defined by product owners or cases where there are documents proving that the medical equipment[692] is not under warranty.

l) To take responsibility to ensure that the medical equipment[693] is only manufactured during the effective period of the Certificate of conformity with quality control standards;

m) To take responsibility before law for the legitimacy and accuracy of the documents posted while conducting the procedures specified in this Decree;

n) To provide medical establishments that buy the medical equipment[694] with 01 set of medical equipment[695] quality control dossier specified in Clause 4, Article 33 of this Decree;

o) [696] To list and declare prices of medical equipment[697] in accordance with this Decree and the law on price.

p) To perform other obligations in accordance with the law.

4. Establishments trading, exporting, importing and transferring medical equipment[698], substances for external quality assessment that contain narcotic substances and precursor shall be responsible for submitting annual reports to the Ministry of Health and the Ministry of Public Security by January 15 of the following year.

5. [699] Responsibilities of organizations and individuals when submitting dossiers of request for performance of the procedures specified in this Decree:

a) To take responsibility before the law for the lawfulness, accuracy of papers and documents included in the dossiers;

b) To ensure the conformity and consistency between information on medical equipment[700] declared in the request and documents in the initially submitted dossier and that declared in supplementary dossiers at the request of the competent authority;

c) To ensure that papers and documents included in the dossiers remain valid throughout the implementation process;

d) To retain papers and documents in the submitted dossier.

Chapter XIII

IMPLEMENTATION PROVISIONS

Article 75. Effect [701]

1. This Decree takes effect from January 01, 2022.

2. The following Decrees shall cease to be effective from the effective date of this Decree:

a) The Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, on prescribing regulations on the management of medical equipment[702];

b) The Government’s Decree No. 169/2018/ND-CP dated December 31, 2018, on amending and supplementing a number of articles of the Government's Decree No. 36/2016/ND-CP dated May 15, 2016, on the management of medical equipment[703];

с) The Government’s Decree No. 03/2020/NĐ-CP dated January 01, 2020, on amending and supplementing Article 68 of the Government’s Decree No. 36/2016/ND-CP dated May 25, 2016, the management of medical equipment[704] which is amended and supplemented in the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018, on amending and supplementing a number of articles of the Government's Decree No. 36/2016/ND-CP dated May 15, 2016, on the management of medical equipment[705];

3. To annul the regulations in Article 7 of the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013m prescribing in details a number of articles of the Law on Advertising from July 01, 2022.

Article 76. Transitional provisions [706]

1. Dossiers of application for circulation registration numbers that were submitted under the Government’s Decree No. 36/2016/ND-CP of May 15, 2016, on management of medical equipment[707], which was amended and supplemented under Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP (below referred to as Decree No. 36/2016/ND-CP) before January 1, 2022, but by the time this Decree takes effect, have yet to be granted circulation numbers, shall be processed as follows:

a) For dossiers of request for registration for circulation of medical equipment[708] of category B, the Ministry of Health shall guide the enterprises that have submitted application dossiers to review and make declaration of applicable standards in accordance with this Decree without having to pay the charge for appraisal and licensing for circulation;

b) For dossiers of request for registration for circulation of medical equipment[709] of categories C and D, if the conditions specified in Clause 3, Article 30 of this Decree are satisfied, the Ministry of Health shall grant circulation numbers according to the procedures specified in Article 32 of this Decree;

c) It is permitted to use the results of classification of medical equipment[710] announced by an organization eligible for classification of medical equipment[711] before the effective date of this Decree for inclusion in dossiers of application for circulation numbers.

2. Regulations on the validity of import licenses; regulations on the import of medical equipment[712] not on the list of medical equipment[713] subject to import licensing:

a) Import licenses for medical equipment[714] other than in-vitro diagnostic biologicals that were granted between January 1, 2018, and December 31, 2021, are valid by the end of December 31, 2024;

b) Import licenses for medical equipment[715] being in-vitro diagnostic biologicals that were issued between January 1, 2018, and December 31, 2021, are valid by the end of December 31, 2024, and no limit on the quantity of imports shall be applied;

c) Organizations that have been granted import licenses specified at Points a and b of this Clause must satisfy the conditions prescribed by law and shall be held responsible for the quality, quantity, categories and use purposes of the imported medical equipment[716]. The Ministry of Health shall inspect, examine, and revoke import licenses in case of violations of regulations on management of medical equipment[717];

d) For medical equipment[718] which is not on the list of medical equipment subject to import licensing (except chemicals, insecticides and germicides for household and medical use that are used only for disinfecting medical equipment[719]), if the documents classifying them as medical equipment[720] of category C or D have been published on the Ministry of Health’s Portal, they may continue to be imported by the end of December 31, 2024, without being subject to any limitations on the quantity of imports and when going through customs clearance procedures, the Ministry of Health’s confirmation of medical equipment[721] shall not be required, regardless of the time of information disclosure on the Ministry of Health’s Portal.

When carrying out import procedures, importers shall declare the serial numbers of documents on results of classification of medical equipment[722] which are conducted by the importers themselves or by organizations qualified to classify medical devices at the importers’ request and shall be held responsible for the quality, quantity, categories and use purposes of the imported medical equipment[723].

Customs offices shall check and collate the information in the documents on results of classification of medical equipment[724] declared by importers on the Ministry of Health’s Portal.

3. Regulations on the validity of circulation numbers, circulation registration certificates and circulation registration numbers:

a) Circulation numbers granted under Decree No. 36/2016/ND-CP before January 1, 2022, are valid for an indefinite period;

b) Circulation registration certificates of domestically produced medical equipment[725] that were issued before January 1, 2022, are valid until the expiry date stated therein;

c) Circulation registration numbers of in-vitro diagnostic biologicals that were granted between January 1, 2014, and December 31, 2019, are valid by the end of December 31, 2024;

d) Circulation registration numbers of medical equipment[726] being in-vitro diagnostic biologicals that were granted between January 1, 2020, and December 31, 2021, are valid by expiry the date stated therein;

dd) Organizations that have been granted circulation registration certificates and circulation registration numbers specified at Point b, c and d of this Clause must meet the conditions prescribed by law and shall be held responsible for the quality, quantity, categories and use purposes of medical equipment[728]. The Ministry of Health shall inspect, examine, and revoke circulation registration certificates and circulation registration numbers in cases of violating regulations on management of medical equipment[729].

4. For applicants that had submitted dossiers of application for licenses for import of medical equipment[730] before January 1, 2022, but not yet been granted import licenses

The Ministry of Health shall notify and guide applicants to complete dossiers for grant of circulation numbers under Decree No. 98/2021/ND-CP and prioritize the processing of these dossiers; in case the applicants wish to apply for import licenses according to the submitted dossiers, the Ministry of Health shall grant import licenses according to the order and procedures specified at Point c of this Clause, if the submitted dossiers contain all required documents and satisfy the requirements specified at Point a or Point b of this Clause.

a) A dossier of application for a license for import of medical equipment[731] on the Minister of Health-promulgated list of medical devices subject to import licensing must comprise:

- An application for an import license;

- A valid certificate of free sale for the category of medical equipment[732] to be imported (the original or a certified copy);

- The manufacturer’s valid ISO 13485 certificate (the original or a copy certified by the applicant);

- A valid power of attorney from the medical equipment[733]’s owner to the importer for import of medical equipment[734](the original or a certified copy);

- The Vietnamese-language technical documents describing the categories of medical equipment[735] to be imported (certified by the applicant);

- The catalogue describing the functions and specifications of the categories of medical equipment[736] to be imported;

- Clinical evaluation reports and use instructions of the owner or manufacturer, for medical equipment[737] being implantable devices and materials of the cardiology and neurology divisions.

b) A dossier of application for an import license for in-vitro diagnostic biologicals must comprise:

- An import order;

- A valid certificate of free sale (the original or a certified copy);

- A valid certificate of conformity with ISO 13485 of the manufacturer (an original or a copy certified by the organization requesting the import);

- The standard and method for quality inspection of medical equipment[738] (certified by the applicant);

- The label and use instructions in Vietnamese, enclosed with the original label and use instructions (certified by the applicant).

c) Order and procedures for grant of an import license:

- In case the application dossier does not need to be modified or supplemented, the Ministry of Health shall grant an import license. In case of refusal to grant an import license, it shall issue a written reply, clearly stating the reason;

- In case the application dossier is incomplete, the Ministry of Health shall notify thereof to the applicant for the latter to supplement or modify the dossier; such notice must specify the documents and contents that need to be modified or supplemented;

- When receiving a request for modification or supplementation of the dossier, the applicant shall modify or supplement the dossier as requested and, at the same time, ensure the conformity and consistency of the modified contents with the previously submitted dossier and send the modified or supplemented dossier to the Ministry of Health within 60 days from the date the Ministry of Health issues the request.

Past 60 days from the date the Ministry of Health issues a request for modification or supplementation of the dossier, if the applicant still fails to submit the modified or supplemented dossier or if the dossier fails to meet requirements though having been modified and supplemented thrice, the Ministry of Health shall refuse to grant the import license of medical equipment[739];

d) Import licenses granted under this Clause are valid by the end of December 31, 2024.

5. Regulations on the application of the ASEAN Common Submission Dossier Template (CSDT) for medical equipment[740]: CSDT dossiers shall be applied on a compulsory basis from January 1, 2024.

6. For dossiers of application for circulation numbers submitted before January 1, 2024, under Article 30 of this Decree:

a) A dossier of application for a circulation number must comprise the papers specified in Article 30 of this Decree, in which the CSDT dossier and CSDT dossier appraisal result specified at Point c, Clause 5, Article 30 of this Decree shall be replaced with the following documents:

- Brief descriptions of technical features of medical equipment[741]: To submit the Vietnamese version, enclosed with the technical documents describing the functions and technical parameters of the medical equipment[742] provided by the owner of the medical equipment[743], certified by the applicant. Particularly for reagents, calibrators and in-vitro control materials: To submit technical documents in Vietnamese, enclosed with documents on raw materials, product safety, manufacture and product quality control processes, and clinical and preclinical research reports, including reports on stability;

- Use instructions of medical equipment[744]: To submit the Vietnamese version certified by the applicant, enclosed with the English original issued by the owner of the medical equipment[745], for imported medical equipment[746];

- The specimen of the label to be used upon circulation in Vietnam of medical equipment[747]: To submit a specimen certified by the applicant. The label specimens must meet the requirements of the law on goods labels.

b) The receipt and appraisal of dossiers of registration for circulation of medical equipment[748] specified in Clauses 1, 2, 3 and 4, Article 30 of this Decree must comply with Article 32 of this Decree.

c) The receipt and appraisal of dossiers of registration for circulation of medical equipment[749] specified in Clause 5, Article 30 of this Decree are as follows:

- If the dossier does not need to be modified or supplemented, the Minister of Health shall organize the appraisal and issue the circulation number within 90 days after receiving a complete and valid dossier (including the written confirmation of payment of the charge for appraisal and grant of circulation licenses according to the Ministry of Finance’s regulations); in case of refusal to issue a circulation number, it shall issue a written reply, clearly stating the reason;

- In case the dossier is incomplete, the Ministry of Health shall send to the applicant a notice of request for supplementation or modification of the dossier, clearly stating the documents and contents that need to be supplemented or modified, and request the applicant to send the supplemented or modified dossier to the Ministry of Health within 60 days from the date the latter issues the notice;

- When receiving the notice of request for supplementation or modification of the dossier of application for a circulation number, the applicant shall modify or supplement the dossier as requested and send the supplemented or modified dossier to the Ministry of Health.

In case the applicant has modified or supplemented the dossier but the dossier remains unconformable with requirements, the Ministry of Health shall notify thereof to the applicant for the latter to complete the dossier under this Clause.

After 90 days after the Ministry of Health issues the notice of request, if the applicant fails to modify or supplement the dossier or if the dossier remains unconformable with requirements though having been modified or supplemented thrice since the Ministry of Health issues the notice of request for modification or supplementation of the dossier for the first time, the applicant shall again carry out procedures for applying for a circulation number.

7. For bidding packages which were opened before April 1, 2022, it is not mandatory to apply the regulation “It is not permitted to purchase and sell medical equipment[750] of which prices have not yet been declared and to purchase and sell medical prices at prices higher than the prices published on the Ministry of Health’s Portal at the time of purchase and sale”.

8. For medical equipment[751] procurement bidding packages for which contractor selection plans were approved before the effective date of this Decree but the bidding dossiers have not yet been posted or issued, in case it is necessary to modify contents related to price declaration, the contractor selection plans shall be modified according to the bidding law.

Article 77. Responsibility for instructions and implementation

1. The Minister of Health shall provide instructions, organize and inspect the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of People’s Committees of provinces and centrally-run cities, and related organizations, agencies and individuals shall implement this Decree./.

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[1] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[2] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[3] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[4] The Government’s Decree No. 07/2023/ND-CP dated December 31, 2018, amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical devices, was promulgated pursuant to:

“Pursuant to the Law on Organization of the Government dated June 19, 2015, and the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

At the proposal of the Minister of Health,

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical devices.”

The Government’s Decree No. 96/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment, was promulgated pursuant to:

“Pursuant to the Law on Organization of the Government dated June 19, 2015, and the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Medical Examination and Treatment dated January 9, 2023;

At the proposal of the Minister of Health,

The Government hereby promulgates the Decree detailing a number of Articles of the Law on Medical Examination and Treatment.”

[5] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[6] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[7] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[8] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[9] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[10] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[11] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[12] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[13] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[14] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[15] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[16] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[17] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[18] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[19] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[20] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[21] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[22] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[23] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[24] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[25] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[26] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[27] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[28] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[29] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[30] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[31] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[32] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[33] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[34] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[35] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[36] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[37] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[38] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[39] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[40] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[41] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[42] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[43] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[44] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[45] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[46] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[47] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[48] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[49] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[50] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[51] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[52] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[53] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[54] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[55] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[56] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[57] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[58] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[59] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[60] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[61] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[62] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[63] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[64] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[65] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[66] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[67] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[68] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[69] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[70] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[71] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[72] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[73] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[74] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[75] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[76] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[77] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[78] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[79] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[80] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[81] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[82] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[83] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[84] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[85] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[86] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[87] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[88] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[89] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[90] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[91] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[92] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[93] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[94] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[95] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[96] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[97] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[98] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[99] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[100] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[101] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[102] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[103] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[104] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[105] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[106] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[107] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[108] This Chapter title is amended under Clause 8, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[109] This Article is amended under Clause 9, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[110] This Article is amended under Clause 10, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[111] This Article is amended under Clause 11, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[112] This Article is amended under Clause 12, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[113] This Article is amended under Clause 13, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[114] This Article is amended under Clause 14, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[115] This Article is amended under Clause 15, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[116] This Article is amended under Clause 16, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[117] This Article is amended under Clause 17, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[118] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[119] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[120] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[121] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[122] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[123] This Clause is amended and supplemented under Clause 1, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[124] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[125] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[126] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[127] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[128] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[129] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[130] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[131] This Article is amended and supplemented under Clause 2, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[132] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[133] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[134] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[135] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[136] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[137] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[138] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[139] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[140] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[141] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[142] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[143] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[144] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[145] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[146] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[147] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[148] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[149] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[150] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[151] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[152] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[153] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[154] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[155] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[156] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[157] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[158] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[159] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[160] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[161] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[162] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[163] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[164] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[165] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[166] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[167] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[168] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[169] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[170] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[171] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[172] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[173] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[174] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[175] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[176] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[177] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[178] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[179] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[180] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[181] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[182] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[183] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[184] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[185] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[186] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[187] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[188] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[189] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[190] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[191] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[192] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[193] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[194] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[195] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[196] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[197] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[198] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[199] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[200] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[201] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[202] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[203] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[204] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[205] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[206] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[207] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[208] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[209] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[210] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[211] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[212] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[213] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[214] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[215] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[216] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[217] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[218] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[219] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[220] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[221] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[222] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[223] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[224] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[225] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[226] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[227] This Clause is supplemented under Point a, Clause 19, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[228] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[229] This Point is amended under Point b, Clause 19, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[230] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[231] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[232] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[233] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[234] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[235] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[236] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[237] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[238] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[239] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[240] This Clause is supplemented under Point c, Clause 19, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[241] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[242] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[243] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[244] This Clause is supplemented under Point d, Clause 19, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[245] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[246] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[247] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[248] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[249] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[250] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[251] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[252] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[253] This Point is amended and supplemented under Clause 3, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[254] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[255] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[256] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[257] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[258] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[259] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[260] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[261] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[262] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[263] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[264] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[265] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[266] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[267] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[268] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[269] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[270] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[271] This Article is supplemented under Clause 21, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[272] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[273] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[274] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[275] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[276] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[277] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[278] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[279] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[280] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[281] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[282] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[283] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[284] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[285] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[286] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[287] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[288] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[289] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[290] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[291] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[292] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[293] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[294] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[295] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[296] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[297] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[298] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[299] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[300] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[301] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[302] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[303] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[304] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[305] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[306] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[307] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[308] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[309] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[310] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[311] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[312] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[313] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[314] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[315] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[316] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[317] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[318] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[319] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[320] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[321] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[322] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[323] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[324] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[325] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[326] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[327] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[328] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[329] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[330] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[331] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[332] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[333] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[334] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[335] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[336] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[337] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[338] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[339] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[340] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[341] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[342] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[343] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[344] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[345] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[346] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[347] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[348] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[349] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[350] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[351] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[352] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[353] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[354] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[355] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[356] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[357] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[358] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[359] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[360] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[361] This Clause is amended and supplemented under Clause 4, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[362] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[363] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[364] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[365] This Section title is amended under Clause 5, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[366] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[367] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[368] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[369] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[370] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[371] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[372] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[373] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[374] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[375] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[376] This Clause is supplemented under Clause 6, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[377] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[378] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[379] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[380] This Clause is supplemented under Clause 7, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[381] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[382] This Article is supplemented under Clause 8, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[383] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[384] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[385] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[386] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[387] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[388] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[389] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[390] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[391] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[392] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[393] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[394] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[395] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[396] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[397] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[398] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[399] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[400] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[401] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[402] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[403] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[404] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[405] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[406] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[407] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[408] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[409] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[410] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[411] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[412] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[413] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[414] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[415] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[416] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[417] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[418] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[419] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[420] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[421] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[422] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[423] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[424] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[425] This Article is amended under Clause 9, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[426] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[427] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[428] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[429] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[430] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[431] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[432] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[433] This Article is amended under Clause 10, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[434] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[435] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[436] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[437] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[438] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[439] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[440] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[441] This Article is amended and supplemented under Clause 11, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[442] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[443] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[444] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[445] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[446] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[447] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[448] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[449] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[450] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[451] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[452] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[453] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[454] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[455] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[456] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[457] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[458] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[459] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[460] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[461] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[462] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[463] This Point is amended under Point a, Clause 12, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[464] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[465] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[466] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[467] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[468] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[469] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[470] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[471] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[472] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[473] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[474] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[475] This Point is supplemented under Point b, Clause 12, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[476] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[477] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[478] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[479] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[480] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[481] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[482] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[483] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[484] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[485] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[486] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[487] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[488] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[489] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[490] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[491] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[492] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[493] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[494] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[495] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[496] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[497] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[498] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[499] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[500] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[501] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[502] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[503] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[504] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[505] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[506] This Clause is amended under Clause 13, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[507] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[508] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[509] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[510] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[511] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[512] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[513] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[514] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[515] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[516] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[517] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[518] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[519] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[520] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[521] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[522] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[523] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[524] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[525] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[526] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[527] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[528] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[529] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[530] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[531] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[532] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[533] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[534] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[535] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[536] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[537] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[538] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[539] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[550] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[541] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[542] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[543] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[544] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[545] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[546] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[547] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[548] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[549] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[550] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[551] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[552] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[553] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[554] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[555] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[556] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[557] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[558] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[559] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[560] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[561] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[562] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[563] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[564] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[565] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[566] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[567] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[568] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[569] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[570] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[571] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[572] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[573] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[574] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[575] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[576] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[577] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[578] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[579] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[580] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[581] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[582] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[583] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[584] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[585] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[586] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[587] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[588] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[589] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[590] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[591] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[592] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[593] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[594] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[595] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[596] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[597] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[598] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[599] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[600] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[601] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[602] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[603] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[604] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[605] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[606] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[607] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[608] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[609] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[610] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[611] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[612] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[613] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[614] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[615] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[616] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[617] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[618] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[619] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[620] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[621] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[622] This Clause is supplemented under Clause 14, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[623] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[624] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[625] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[626] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[627] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[628] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[629] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[630] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[631] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[632] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[633] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[634] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[635] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[636] This Clause is amended and supplemented under Point a, Clause 15, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[637] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[638] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[639] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[640] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[641] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[642] This Clause is amended and supplemented under Point b, Clause 15, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[643] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[644] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[645] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[646] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[647] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[648] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[649] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[650] This Clause is supplemented under Point c, Clause 15, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[651] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[652] This Clause is supplemented under Point c, Clause 15, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[653] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[654] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[655] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[656] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[657] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[658] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[659] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[660] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[661] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[662] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[663] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[664] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[665] This Clause is amended under Clause 16, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[666] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[667] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[668] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[669] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[670] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[671] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[672] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[673] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[674] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[675] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[676] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[677] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[678] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[679] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[680] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[681] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[682] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[683] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[684] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[685] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[686] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[687] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[688] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[689] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[690] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[691] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[692] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[693] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[694] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[695] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[696] This Point is amended under Point a, Clause 17, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[697] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[698] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[699] This Clause is supplemented under Point b, Clause 17, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[700] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[701] Articles 2 and 3 of the Government’s Decree No. 07/2023/ND-CP dated March 3, 2023, amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical devices, which took effect on March 3, 2023, prescribes as follows:

“Article 2. Implementation provisions

This Decree takes effect from the date of its signing.

Article 3. Responsibilities of implementation

1. The Minister of Health shall provide instructions, organize and inspect the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees and related agencies, organizations and individuals shall implement this Decree./.”

Clauses 1 and 20, Article 147 and Article 148 of the Government’s Decree No. 20/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment, which took effect from January 1, 2024, prescribes that:

“Article 147. Effect

1. This Decree takes effect from January 1, 2024.

20. The provisions in Clause 5, Article 105 of this Decree and Clause 19 of this Article shall be applied from January 1, 2026.

Article 148. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees and related agencies, organizations and individuals shall implement this Decree.”

[702] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[703] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[704] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[705] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[706] This Article is amended and supplemented under Clause 18, Article 1 of Decree No. 07/2023/ND-CP, which took effect from March 3, 2023.

[707] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[708] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[709] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[710] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[711] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[712] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[713] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[714] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[715] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[716] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[717] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[718] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[719] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[720] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[721] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[722] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[723] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[724] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[725] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[726] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[727] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[728] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[729] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[730] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[731] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[732] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[733] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[734] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[735] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[736] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[737] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[738] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[739] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[740] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[741] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[742] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[743] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[744] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[745] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[746] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[747] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[748] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[749] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[750] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[751] The phrase “medical devices” is replaced with the phrase “medical equipment” under Clause 7, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[752] A written request for approval of clinical trial research of the organization or individual that has medical equipment subject to clinical trials in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point a, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[753] A written request for approval of clinical trial research of the clinical trial-hosting establishment in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point b, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[754] A written explanation of the protocol of the clinical trial of the medical equipment in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point c, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[755] A written request for approval of changes in the clinical trial of the medical equipment in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point d, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[756] A written request for approval of outcomes of the clinical trial of the medical equipment in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point dd, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.

[757] A clinical study report of the clinical trial of the medical equipment in the dossier of application for approval of medical equipment clinical trials specified in Article 17 of this Decree shall be additionally provided in accordance with Point e, Clause 18, Article 147 of Decree No. 96/2023/ND-CP, which took effect from January 1, 2024.