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

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Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices
Issuing body: GovernmentEffective date:
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Official number:07/2023/ND-CPSigner:Tran Hong Ha
Type:DecreeExpiry date:Updating
Issuing date:03/03/2023Effect status:
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Fields:Medical - Health

SUMMARY

A number of licenses to import medical devices may be used until 2024

On March 03, 2023, the Government issues Decree No. 07/2023/ND-CP amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

Accordingly, import licenses of medical devices other than in vitro diagnostic reagents that are granted in the period of between January 1, 2018, and December 31, 2021, shall continue to be used until the end of December 31, 2024; import licenses of medical devices being in vitro diagnostic reagents that are granted in the period of between January 1, 2018, and December 31, 2021, shall continue to be used until the end of December 31, 2024 without limits on import quantities.

Besides, registration numbers of medical devices being in vitro diagnostic reagents that are granted in the period of between January 1, 2014, and December 31, 2019, shall continue to be used until the end of December 31, 2024. For medical devices being in vitro diagnostic reagents that have been granted registration number in the period of between January 01, 2020, and December 31, 2021, such registration numbers shall be valid until the expiry dates written on the registration certificates.

Organizations with circulation registration certificates and registration numbers must satisfy the requirements as prescribed by law, and take responsibility for ensuring quality, quantities, types and intended purposes of their medical devices. The Ministry of Health shall inspect, examine and revoke circulation registration certificates and registration numbers of cases violating regulations on medical device management.

This Decree takes effect on the signing date.

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THE GOVERNMENT

_________

No. 07/2023/ND-CP

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

________________________

Hanoi, March 03, 2023

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices

_______________

 

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;

At the proposal of the Minister of Health,

The Government hereby promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

 

Article 1. Amending and supplementing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices

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

“2. Marketing authorization number holder is the organization that declares applicable standards for medical device or that is granted the certificate of registration for circulation of medical device in accordance with this Decree.”.

2. To amend and supplement Article 22 as follows:

“Article 22. Conditions for placement of medical devices on the market

1. A medical device may be placed on the market if it meets the following conditions:

a) It has been granted a registration number, market authorization number, certificate of registration for circulation, import license in accordance with provisions on the management of medical devices, or the cases specified at Point d Clause 2 Article 76 of this Decree, except for the following cases:

- It is liquidated in accordance with law;

- The product is expired;

- Failure to remedy the errors that adversely affect the health of users in accordance with Clause 4 Article 34 of this Decree;

- It is banned from use by the competent state agencies.

b) Its label contains adequate information in accordance with the law provisions on labeling of goods;

c) Instructions for use of the medical device are given in Vietnamese;

d) It has information about the warranty center, conditions, and time for warranty, unless otherwise such medical device is single-use medical device as defined by product owners or there are documents proving that it is not under warranty.

2. If the medical device has an import license as prescribed at Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the conditions specified at Point d Clause 1 of this Article are not required.

3. In case where the information prescribed at Point c and Point d Clause 1 of this Article is not provided with the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.”.

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

“c) When receiving a request for supplementing or amending the dossier for grant of market authorization 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 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 market authorization number must be carried out from the beginning.”.

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

“6. In case where the Ministry of Health issues a written refusal to permit the marketing authorization for medical devices under Clause 5 of this Article, the market authorization number holder or distributor shall recall all medical devices circulated on the market, except for those that have been sold to health establishments or users.”.

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

“Section 5. REVOCATION OF MARKET AUTHORIZATION NUMBERS OF MEDICAL DEVICES, AND HANDLING OF MEDICAL DEVICES WITH REVOKED MARKET AUTHORIZATION NUMBERS”

6. To add Clause 14 Article 38 as follows:

“14. The document composition of the application dossiers for registration of circulation of medical devices is not in accordance with the provisions of law as concluded by competent agencies.”.

7. To add Clause 6 Article 39 as follows:

“6. Upon receiving conclusions from competent agencies specified in Clause 14 Article 38 of this Decree, within 05 working days after receiving the competent agencies’ documents, the agency granting the marketing authorization number shall consider and issue a document to revoke the marketing authorization number under the management.

After issuing the revocation document, competent agencies shall carry out procedures specified in Clause 3, Clause 4 of this Article.”.

8. To add Article 39a as follows:

“Article 39a. Handling of medical devices whose marketing authorization numbers have been revoked

1. Medical devices already sold to health establishments or users shall continue to be used until they are liquidated in accordance with law, or until their expiry date, except for those with errors adversely affecting the users’ health, as prescribed in Clause 4 Article 34 of this Decree, cannot be remedied.

2. For medical devices with revoked marketing authorization numbers which have not yet been sold to users or health establishments, the marketing authorization number holders shall suspend the circulation of such medical devices and take measures to recall them.”.

9. To amend Article 44 as follows:

“Article 44. Listing of medical device prices

1. Organizations and individuals manufacturing and trading medical devices shall list medical device prices at places specified in Article 17 of the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013, detailing and guiding a number of articles of the Law on Price, or the Ministry of Health’s e-portal.

2. In case of listing medical device prices on the Ministry of Health's e-portal, the following information is required:

a) Name and type of medical devices;

b) Manufacturer and manufacturing country; product owner and country of product owner;

c) Unit of calculation;

d) Configuration and technical functions of the medical devices;

dd) Listed prices of medical devices.”.

10. To amend Article 45 as follows:

“Article 45. Declaration of medical device prices

1. Manufacturers and traders must declare the prices; declaration contents and procedures shall comply with the law on prices.

2. Based on actual situation and unexpected fluctuations in terms of prices that affect the sources of providing medical devices, and payment ability of buyers, solvency of the Health Insurance Fund, the Minister of Health shall issue, update, amend and supplement the lists and provide guidance on medical devices subject to price declaration.

3. Organizations and individuals manufacturing and trading medical devices shall make price declarations according to the forms specified by the law on prices or on the Ministry of Health's e-portal.”.

11. To amend and supplement Article 46 as follows:

“Article 46. Principle for management of import and export of medical devices

1. Importers and exporters of medical devices must satisfy the requirements as prescribed in the law on import and export and assume the responsibility for ensuring quality, quantities, types and intended purposes of their imported/exported medical devices.

2. Medical devices that have been granted marketing authorization numbers in Vietnam may be exported and imported without limits on quantities and without the Ministry of Health’s approval.

3. Medical devices specified in Clause 1 Article 48 of this Decree that are imported for use in Vietnam must obtain import licenses.

4. Medical devices other than those specified in Clauses 2 and 3 of this Article which are brought into Vietnam by other forms shall comply with the law on foreign trade management.

5. The issuance of certificates of free sale for medical devices shall comply with the law on foreign trade management.

6. The import of used medical devices shall comply with lthe 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 a marketing authorization number, that are imported for use in health establishments and procured from (official development assistance) ODA and concessional loans, non-refundable aid not belonging to ODA.”.

b) To add Point o Clause 2 Article 48 as follow:

“o) For case of import specified at Point e Clause 1 of this Article, the application dossier for a license must comprise additional documents as follows:

- An original or a certified copy of the decision on approval of the investment policy, and investment decision (for investment projects), or a decision on approval of investment documents (for technical support projects), project expenses or non-refundable aid not belonging to ODA, clearly stating the import of medical devices;

- An original or a certified copy of the contract of provisions of medical devices for the project;

- A power of attorney of the product owner on authorizing the organization to apply the import license, which remains valid at the time dossier submission. A consularly legalized copy or a certified copy of the consularly legalized copy is required;

- A certificate of eligibility for providing warranty services granted by the product owner, unless otherwise such medical device is single-use medical device as defined by the product 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 certificate of free sale, which remains valid when the dossier is submitted, for an imported medical device. A consularly legalized copy or a certified copy of the consularly legalized copy is required; In cases where the market 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.”.

13. To amend Clause 3 Article 52 as follows:

“3. Listing and declaring medical device prices in accordance with this Law and the law on prices.”.

14. To add Clause 12 Article 66 as follows:

“12. In case where procedures specified in this Decree contain dossier composition considered confidentiality as prescribed by law, the confidential documents and information relating to the licensing of such dossier shall be submitted directly and preserved according to the confidentiality regime.”.

15. To amend and supplement Article 70 as follows:

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

“5. To publish the following information on the Ministry of Health’s e-portal:

a) Prices of winning bids for medical devices of State-owned health establishments nationwide;

b) List of medical devices whose marketing authorization numbers have been revoked;

c) List of organizations and individuals forging dossiers, or violating regulations on the management of medical devices in accordance with this Decree.”.

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 carrying out the inspection, examination and settlement of complaints, denunciations and taking actions against violations in the field of medical devices in accordance with this Decree and law provisions.”.

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

“13. To announce and modify the list of medical devices subject to price declaration for management requirement according to actual situation.

14. To provide guidance on medical devices subject to price declaration.”.

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

“5. To assume the prime responsibility for organizing and carrying out procedures under this Decree, carrying out the inspection, examination and settlement of complaints, denunciations and taking actions against violations in the field of medical devices and prices in the provinces in accordance with law provisions.".

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 medical device prices in accordance with this Law and the law on prices.”.

b) To add Clause 5 Article 74 as follows:

“5. Responsibility of organizations and individuals submitting dossiers for carrying out 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 consistency and conformity in terms of medical device information stated in the written request and the initial application dossiers for licenses, for additional dossiers at request of the competent agencies;

c) To ensure papers and documents of the dossiers remaining valid during the implementation;

d) To take responsibility for retaining papers and documents in the submitted dossiers.”.

18. To amend and supplement Article 76 as follows:

“Article 76. Transitional provisions

1. Application dossiers for marketing authorization numbers that have been submitted in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, on the management of medical devices, which was amended and supplemented under Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP (hereinafter referred to as Decree No. 36/2016/ND-CP) before January 1, 2022 to the effective date of this Decree but have not yet been granted a marketing authorization number shall be handled as follows:

a) For application dossiers for circulation registration of Class-B medical devices, the Ministry of Health shall instruct the applicants to review to declare the applied standards in accordance with this Decree without re-paying charges for appraisal and licensing;

b) For application dossiers for circulation registration of Class-C or -D medical devices, if they meet the requirements specified in Clause 3 Article 30 of this Decree, the Ministry of Health shall issue the marketing authorization numbers in accordance with the procedures specified in Article 32 of this Decree;

c) It is possible to use the medical device classification results announced by the classification organization qualified to classify medical devices before the effective date of this Decree in the application dossiers for marketing authorization number.

2. Provisions on the validity of import licenses; the import of medical devices other than those in the list of medical devices subject to import licenses:

a) Import licenses of medical devices other than in vitro diagnostic reagents that are granted in the period of between January 1, 2018, and December 31, 2021, shall continue to be used until the end of December 31, 2024;

b) Import licenses of medical devices being in vitro diagnostic reagents that are granted in the period of between January 1, 2018, and December 31, 2021, shall continue to be used until the end of December 31, 2024 without limits on import quantities;

c) Organizations with import licenses specified at Points a and b of this Clause must satisfy the requirements as prescribed by law, and take responsibility for ensuring quality, quantities, types and intended purposes of their imported medical devices. The Ministry of Health shall inspect, examine and revoke import licenses of cases violating regulations on medical device management;

d) Medical devices which are not required to obtain the import license (except for insecticidal and germicidal chemicals and preparations for medical and household use which are used solely for disinfection of medical devices) and have been classified as Class-C or -D medical devices as announced on the Ministry of Health’s e-portal may continue to be imported until December 31, 2024 without limits on quantities and written confirmation as medical devices from the Ministry of Health when conducting the customs clearance, regardless of the announcing time on the Ministry of Health's e-portal.

When carrying out import procedures, importers must declare the number of documents on medical device classification results that they have made or requested qualified organizations to make, and take responsibility for ensuring quality, quantity, type and intended purposes of their imported medical devices.

Customs offices shall check and compare information in the documents on medical device classification results of importers declaring information on the Ministry of Health’s e-portal.

3. Provisions on the validity of the marketing authorization numbers, circulation registration certificates and registration numbers:

a) Marketing authorization numbers granted in accordance with Decree No. 36/2016/ND-CP before January 1, 2022, shall remain valid forever;

b) Certificates of registration for circulation of domestically manufactured medical devices that are granted before January 1, 2022, shall remain valid until the expiry date stated on such certificates;

c) Registration numbers of medical devices being in vitro diagnostic reagents that are granted in the period of between January 1, 2014, and December 31, 2019, shall continue to be used until the end of December 31, 2024;

d) Medical devices being in vitro diagnostic reagents that have been granted registration number in the period of between January 01, 2020, and December 31, 2021, such registration numbers shall be valid until the expiry dates written on the registration certificates;

dd) Organizations with circulation registration certificates and registration numbers specified at Points b, c and d of this Clause must satisfy the requirements as prescribed by law, and take responsibility for ensuring quality, quantities, types and intended purposes of their medical devices. The Ministry of Health shall inspect, examine and revoke circulation registration certificates and registration numbers of cases violating regulations on medical device management.

4. Regarding importers requesting the grant of licenses to import medical devices that have submitted dossiers before January 1, 2022 but have not yet been granted an import license.

The Ministry of Health shall notify and guide enterprises to complete the dossiers to grant marketing authorization numbers in accordance with Decree No. 98/2021/ND-CP, and consider giving priority for such enterprises in processing their dossiers. In case where they continue applying 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 are complete and satisfy requirements specified at Point a or b of this Clause.

a) A dossier of application for a license to import medical devices in the list of devices requiring an import license issued by the Minister of Health must comprise:

- A written request for import license;

- An original or certified copy of a valid certificate of free sale for the types of medical devices;

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

- An original or a certified copy of the valid power of attorney of the product owners authorizing an organization or individual to import medical devices;

- Technical documents describing the type of imported medical devices, made in Vietnamese (certified by the organization requesting the import);

- Catalogues describing functions and technical specifications of the types of imported medical devices;

- Written clinical assessment and user manuals of the owner or manufacturer for medical devices that are types of devices and materials that interfere with the body in the specialty of cardiology, cranial nerves.

b) An application dossier for a license to import in vitro diagnostic reagents must comprise:

- An import order;

- An original or certified copy of a valid certificate of free sale;

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

- Criteria and methods for examining medical device quality (certified by the organization requesting the import);

- Labels and user manuals in Vietnamese, accompanied with original labels and user manuals (certified by the organization requesting the import).

c) Order and procedures for licensing the import:

- In case the application dossier for import license is not required to be amended or supplemented, the Ministry of Health shall grant an import license. In case of refusal to grant an import license, a written reply clearly stating the reason is required;

- In case where the application dossier for import license is incomplete, the Ministry of Health shall notify the applicant to amend and supplement the dossier, clearly specifying documents and contents to be amended and supplemented;

- Upon receiving the request for amendment and supplement of the dossier, the applicant shall amend and supplement as requested, and concurrently, take responsibility for ensuring the conformity and consistency of the amended contents compared to the previously submitted dossier, and send it to the Ministry of Health within 60 days after the Ministry of Health issues the notice.

Past 60 days from the date on which the Ministry of Health requests to amend and supplement, if the applicant fails to submit the amended and supplemented dossier, or after 3 times of amendment and supplement, if the dossier still fails to satisfy requirements, the Ministry of Health shall refuse to grant an import license;

d) The import license issued in accordance with this Clause shall be valid until the end of December 31, 2024.

5. Provisions on applying the common submission dossier template (CSDT): CSDT shall be compulsory from January 01, 2024.

6. Regarding application dossiers for marketing authorization numbers submitted before January 1, 2024 under Article 30 of this Decree:

a) An application dossier for marketing authorization number must comprise papers specified in Article 30 of this Decree, in which the CSDT and result of appraising the CSDT specified at Point c Clause 5 Article 30 if this Decree are replaced with the following papers and requirements:

- A synopsis of the technical description of the medical device in Vietnamese, accompanied with a technical description of function and technical specification of the medical device issued by the product owner, certified by the applicant. For in vitro diagnostic reagents, calibrators and control materials: the synopsis of technical description in Vietnamese language must be accompanied with documents on the materials, the safety of the product, the manufacturing and safety control process, pre-clinical and clinical study reports including the stability report;

- User manual of the medical device: submit the copy in Vietnamese with the certification of the applying organization, accompanied by the original copy in English issued by the product owner, for imported medical device;

- A sample of the label for the medical device if it is sold in Vietnam: submit the sample label with the certification of the applying organization. The sample label must meet requirements in accordance with the law on labeling of goods.

b) The receipt and appraisal of application dossiers for circulation registration of medical devices specified in Clauses 1, 2, 3 and 4 Article 30 of this Decree shall comply with Article 32 of this Decree.

c) The receipt and appraisal of application dossiers for circulation registration of medical devices prescribed in Clause 5 Article 30 of this Decree shall be conducted as follows:

- If there is no requirement to amend, supplement the application dossier, the Minister of Health shall be responsible for: Organizing the appraisal and issuance of the marketing authorization number within 90 days from the date on which a complete and valid dossier is received (including receipt of charges for appraisal for granting a marketing authorization permit as prescribed by the Ministry of Finance). In cases of refusal, a written response indicating reasons for such refusal is required;

- In cases where the dossier is incomplete, the Ministry of Health shall send a written notice to the applicant for supplementing or amending the dossier, specifying which documents and contents to be amended, supplemented, and sent to the Ministry of Health within 60 days from the date on which the Ministry of Health sends such notice;

- When receiving a request for supplementing or amending the dossier for grant of market authorization 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 the applicant to continue to complete the dossier in accordance with this Clause.

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 market authorization number must be carried out from the beginning.

7. Provisions “Not trading medical devices before their prices are declared or not trading medical devices at prices higher than those publicized on the Ministry of Health’s e-portal at the time of trading” are not compulsory for bid packages opened before April 1, 2022.

8. For bid packages for medical device procurement of which the contractor selection plans are approved before the effective date of this Decree but the notices have not yet been publicized or bidding dossiers have not yet been issued, the contractor selection plans shall be adjusted in accordance with the bidding law in case of necessary.”.

Article 2. Effect

This Decree takes effect on 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 People’s Committees of provinces and centrally-run cities, and related organizations, agencies and individuals shall be responsible for the implementation of this Decree./.

 

 

ON BEHALF OF THE GOVERNMENT

FOR THE PRIME MINISTER

THE DEPUTY PRIME MINISTER

 

 

Tran Hong Ha

 

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