Vietnam Ministry of Health amended and supplemented Clause 2, 3, and 4 of Article 76 of Decree No. 98/2021/ND-CP dated November 8, 2021. These updates aim to provide continuity for businesses by extending the validity of import licenses and registration numbers for certain medical devices.

Key Updates:

1. Import Licenses for General and IVD Medical Devices (Clause 2):

• Import Licenses issued between January 1, 2018, and December 31, 2021, are now valid until June 30, 2025.
• Class C and D medical devices that do not require import licenses (excluding chemicals, insecticides, or disinfectants for medical device disinfection) can be imported using published risk classification results until June 30, 2025. There are no quantity limits, and Ministry confirmation is not needed for customs clearance.
• Importers must declare classification details and are responsible for ensuring device quality, quantity, and intended use. Customs will verify the declared information.

 

2. Validity of Registration Numbers for IVD Medical Devices (Clause 3):

• Registration numbers issued between January 1, 2014, and December 31, 2019, remain valid until June 30, 2025.

 

3. Extension of Import Licenses (Clause 4)

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

 

 

What This Means:

• Businesses can continue importing general and IVD medical devices without disruption while awaiting registration approval under Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.
• The extended validity reduces administrative burdens and allows for smoother operations.

 

These amendments aim to support stakeholders by providing clarity and continuity in the regulatory process.

 

 

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