Vietnam Ministry of Health amended, supplemented Clause 2, Clause 3, and Clause 4, Article 76 of Decree No. 98/2021/ND-CP dated November 8, 2021.

The amendment and additions are as follows:

1. Clause 2: Validity Extension for Import Licenses: Point a, b, c, d, Article 76

• Import Licenses for general and IVD medical devices issued from January 1, 2018, to December 31, 2021, are valid until June 30, 2025.
• Class C and D medical devices not requiring import licenses (except chemicals, insecticides, disinfectants used in household and medical fields with the sole purpose of disinfecting medical device) can be imported using published risk classification result until June 30, 2025, without quantity limits or Ministry confirmation for customs clearance.
• Importers must declare classification details and are responsible for device quality, quantity, and intended use. Customs will verify the declared information.

Implication for Businesses:
This extension provides medical device importers with greater flexibility and stability, reducing delays and uncertainties while awaiting full registration approval.

2. Clause 3: Extension of Registration Number Validity for IVD Devices:  Point c, Article 76

• The registration numbers for IVD medical devices issued from January 1, 2014, to December 31, 2019, remain valid until June 30, 2025.

Implication for Businesses:
This ensures that IVD device manufacturers and importers can continue their operations without disruptions, preventing supply chain bottlenecks.

 

3. Clause 4: Extended Validity for Import Licenses: Point d, Article 76

• Import licenses issued under Clause 4 are valid until June 30, 2025.

 

Conclusion: Ensuring Uninterrupted Medical Device Supply
Decree No. 04/2025/ND-CP extended the validity until June 30, 2025, for Import Licenses for general and IVD medical devices granted between 2018/01/01 and 2021/12/31, and The Registration Number for IVD medical device granted between 2014/01/01 and 2019/12/31. The extension will allow businesses to continue importing medical devices without disruption while waiting for registration approval under Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.

 

References:
Decree No. 04/2025/BYT-HTTB dated January 1st , 2025, amending and supplementing Decree No. 98/2021/ND-CP, as revised by Decree No. 07/2023/ND-CP