Nghị định 04/2025/NĐ-CP ngày 01/01/2025 sửa đổi Nghị định 98/2021/NĐ-CP về quản lý thiết bị y tế đã được sửa đổi theo Nghị định 07/2023/NĐ-CP

DECREE

AMENDMENTS TO GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED NOVEMBER 08, 2021 PRESCRIBING MEDICAL DEVICE MANAGEMENT AS AMENDED IN GOVERNMENT’S DECREE NO. 07/2023/ND-CP DATED MARCH 03, 2023

Pursuant to the Law on Government Organization dated June 19, 2015; the Law on Amendments to the Law on Government Organization and the Law on Local Government Organization dated November 22, 2019;

And at the request of the Minister of Health of Vietnam;

The Government promulgates a Decree providing amendments to Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 prescribing medical device management as amended in Government’s Decree No. 07/2023/ND-CP dated March 03, 2023.

Article 1. Amendments to clauses 2, 3, and 4 Article 76 of Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 prescribing medical device management as amended in Government’s Decree No. 07/2023/ND-CP dated March 03, 2023

1. Clause 2 Article 76 of the Decree No. 98/2021/ND-CP is amended as follows:

“2. Regulations on validity of import license and import of medical devices which are not included in the list of medical devices subject to import license requirements:

a) An import license for medical devices other than IVD reagents which is issued within the period from January 01, 2018 to December 31, 2021 shall remain valid until June 30, 2025 inclusively;

b) An import license for medical devices which are IVD reagents which is issued within the period from January 01, 2018 to December 31, 2021 shall remain valid until June 30, 2025 inclusively and impose no limit on import quantities;

c) Holders of import license prescribed in Points a and b of this Clause shall meet relevant eligibility requirements laid down in laws and assume responsibility for quality, quantity, categories and uses of their imported medical devices. The Ministry of Health of Vietnam shall carry out inspections and consider revoking the import license in case of violations against regulations on management of medical devices;

d) The import of medical devices which are not subject to import license requirements (except insecticidal and germicidal chemicals and preparations for medical and household use which are used for disinfection of medical devices only) and have been classified as Class-C or D medical devices as published on the web portal of the Ministry of Health of Vietnam may continue until the end of June 30, 2025 without limits on import quantities and requiring the Ministry of Health of Vietnam’s confirmation as medical devices, regardless of the time of publishing information on such medical devices on the web portal of the Ministry of Health of Vietnam.

When following import procedures, the importer shall declare the number of document indicating medical device classification results given by itself or by a qualified classification body and shall assume responsibility for quality, quantity, categories and uses of imported medical devices.

Customs authorities shall verify the document indicating medical device classification results declared by the importer on the web portal of the Ministry of Health of Vietnam.”.

2. Point c Clause 3 Article 76 of the Decree No. 98/2021/ND-CP is amended as follows:

“c) Marketing authorization numbers of medical devices which are IVD reagents issued within the period from January 01, 2014 to December 31, 2019 shall remain valid until June 30, 2025 inclusively;”.

3. Point d Clause 4 Article 76 of the Decree No. 98/2021/ND-CP is amended as follows:

“d) An import license issued according to the provisions of this Clause shall be valid until June 30, 2025, inclusively.”.

Article 2. Effect

This Decree comes into force from the day on which it is signed.

Article 3. Responsibility for implementation

1. The Minister of Health of Vietnam shall instruct, organize and inspect the implementation of this Decree.

2. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of Provincial People’s Committees and relevant authorities, organizations and individuals are responsible for the implementation of this Decree.

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