Decree 07/2023/ND-CP amend Decree 98/2021/ND-CP on the management of medical devices

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^[1]

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

At the request 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.

Article 1. To amend and supplement a number of articles of the Government’s Decree No. 98/2021/ND-CP of November 8, 2021, on management of medical devices (below referred to as Decree No. 98/2021/ND-CP)

1. To amend and supplement Clause 2, Article 21 as follows:

“2. The circulation registration number holder is the organization declaring the standards applicable to medical devices or the organization having been granted a circulation registration certificate for medical devices in accordance with this Decree.”.

2. To amend and supplement Article 22 as follows:

“Article 22. Conditions for circulation of medical devices

1. In order to be circulated in the market, medical devices 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 devices or falling into the case specified at Point d, Clause 2, Article 76 of this Decree, except:

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

- Medical devices the shelf life of which has expired;

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

- Medical devices 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;

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

2. For medical devices 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 devices, it must be provided in the form of electronic information and the medical devices’ labels must display instructions for searching for information.”.

3. To amend and supplement Point c, Clause 3, Article 32 as follows:

“c/ When receiving a notice of request for modification or supplementation of its dossier of application for a circulation number, the applicant shall modify or supplement the dossier as requested in the notice and send it to the Ministry of Health.

In case the applicant has modified or supplemented its dossier but still fails to meet the requirements, the Ministry of Health shall notify the applicant thereof for the latter to complete the dossier according to Point b, Clause 3 of this Article.

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 .” 

4. To amend and supplement Clause 6, Article 37 as follows:

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

5. To amend the title of Section 5, Chapter V as follows:

“Section 5

REVOCATION OF CIRCULATION NUMBERS OF MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES SUBJECT TO REVOCATION OF CIRCULATION NUMBERS”

6. To add Clause 14 to Article 38 as follows:

“14. The documents included in the dossier of request for registration for circulation of medical devices are concluded by a competent authority to be incompliant with the provisions of law.”.

7. To add Clause 6 to Article 39 as follows:

“6. 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.”.

8. To add Article 39a as follows:

“Article 39a. Handling of medical devices after their circulation numbers are revoked

1. Medical devices 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 devices 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 devices 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 devices and take measures to withdraw medical devices”.

9. To amend Article 44 as follows:

“Article 44. Listing of prices of medical devices

1. Manufacturers and traders of medical devices shall list prices of the medical devices 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 device on the Portal of the Ministry of Health, at least the following information is required:

a/ Name and type of the medical device;

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

c/ Unit of calculation;

d/ Configuration and technical features of the medical device;

dd/ Listed price of the medical device.”.

10. To amend Article 45 as follows:

“Article 45. Declaration of prices of medical devices

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

2. When there is an abnormal fluctuation in prices affecting the supply of medical devices, 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 devices subject to price declaration and guide the provision of information on these medical devices.

3. Manufacturers and traders of medical devices shall declare prices of the medical devices in the forms specified in the law on price or on the Portal of the Ministry of Health.”.

11. To amend and supplement Article 46 as follows:

“Article 46. Principles of management of import and export of medical devices

1. Medical device 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 devices they import or export.

2. Medical devices 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 devices falling into the cases specified in Clause 1, Article 48 of this Decree, when imported for use in Vietnam.

4. Medical devices 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 devices must comply with the law on foreign trade management.

6. The import of used medical devices must comply with the law on foreign trade management.”.

12. To amend and supplement Article 48 as follows:

a/ To amend Point e, Clause 1, Article 48 as follows:

“e/ Medical devices 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”.

b/ To add Point o to Clause 2 Article 48 as follows:

“o/ 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 devices;

- The original or a certified copy of the contract on supply of medical devices to the projects;

- The power of attorney made by the owner of the medical devices 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;

- The certificate of eligibility for warranty issued by the owner of the medical devices, except disposable medical devices under regulations of the medical device owners or in case there are documents proving that no warranty regime is applied: to submit a consularly legalized copy or a certified copy of the consularly legalized copy;

- The circulation certificate which must remain valid at the time of dossier submission, for imported medical devices: to submit the consularly legalized copy or a certified copy of the consularly legalized copy. In case the circulation certificate is made in a language other than English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with law.”.

13. To amend Clause 3, Article 52 as follows:

“3. To list and declare prices of medical devices in accordance with this Decree and the law on price.”.

14. To add Clause 12 to Article 66 as follows:

“12. 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.”.

15. To amend and supplement Article 70 as follows:

a/ To amend and supplement Clause 5, Article 70 as follows:

“5. To publish on the Ministry of Health’s Portal information about:

a/ The winning bids of medical device procurement packages of state-run medical establishments nationwide;

b/ The list of medical devices 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 devices.”.

b/ To amend and supplement Clause 7, Article 70 as follows:

“7. 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 devices in accordance with law and this Decree.”.

c/ To add Clauses 13 and 14 to Article 70 as follows:

“13. To publish and modify the list of medical devices subject to price declaration according to management requirements and actual situation.

14. To issue instructions on provision of information of medical devices subject to price declaration.”.

16. To amend and supplement Clause 5, Article 73 as follows:

“5. 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 devices and in the field of price for medical devices occurring in the provincial-level locality in accordance with law.”.

17. To amend and supplement Article 74 as follows:

a/ To amend Point o, Clause 3, Article 74 as follows:

“o/ To list and declare prices of medical devices in accordance with this Decree and the law on price.”.

b/ To add Clause 5 to Article 74 as follows:

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

a/ To be held responsible before law for the lawfulness and accuracy of the papers and documents included in the dossier;

b/ To ensure the conformity and consistency between information on medical devices 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.”.

18. To amend and supplement Article 76 as follows:

“Article 76. Transitional provisions

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 devices, 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 devices 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 devices 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 devices announced by an organization eligible for classification of medical devices 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 devices not on the list of medical devices subject to import licensing:

a/ Import licenses for medical devices 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 devices 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 devices. The Ministry of Health shall inspect, examine, and revoke import licenses in case of violations of regulations on management of medical devices;

d/ For medical devices which are not on the list of medical devices subject to import licensing (except chemicals, insecticides and germicides for household and medical use that are used only for disinfecting medical devices), if the documents classifying them as medical devices 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 devices 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 devices 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 devices.

Customs offices shall check and collate the information in the documents on results of classification of medical devices 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 devices 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 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 devices. 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 devices.

4. For applicants that had submitted dossiers of application for licenses for import of medical devices 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 devices 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 devices 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 authorization letter from the medical devices’ owner to the importer (the original or a certified copy);

- The Vietnamese-language catalogue describing the categories of medical devices to be imported (certified by the applicant);

- The catalogue describing the functions and specifications of the categories of medical devices to be imported;

- Clinical evaluation reports and use instructions of the owner or manufacturer, for medical devices that are 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:

- The import order;

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

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

- The standard and method for quality inspection of medical devices (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;

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 devices: 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 devices: To submit the Vietnamese version, enclosed with the catalogue describing the functions and technical parameters of the medical devices provided by the owner of the medical devices, certified by the applicant. Particularly for reagents, calibrators and in-vitro control materials: To submit catalogues 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 devices: To submit the Vietnamese version certified by the applicant, enclosed with the English original issued by the owner of the medical devices, for imported medical devices;

- The specimen of the label to be used upon circulation in Vietnam of medical devices: 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 devices 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 devices 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 devices 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 device 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 2. Implementation provision

This Decree takes effect on the date of its signing.

Article 3. Responsibility for organization of implementation

1. The Minister of Health shall guide, 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.-

On behalf of the Government
For the Prime Minister
Deputy Prime Minister
TRAN HONG HA