The Circular 10/2023/TT-BYT was issued on May 11, 2023, amending some templates of the Circular 19/2021/TT-BYT, which specifies templates, reports, and documents for the implementation of Decree 98/2021/ND-CP.

The following templates have been updated:

• ● Declaration letter for applicable standards for medical devices in classes A and B;
• ● Application form for product registration of medical devices in classes C and D;
• ● Approvals of declaration dossiers for applicable standards for medical devices in classes A and B;
• ● Registration certificate for medical devices in classes C and D;
• ● Import licenses for medical devices;
• ● Certificate of Free Sale;
• ● Letter of Authorization for the import permit of medical devices;
• ● A brief description for product registration of imported medical devices.

The following templates have been supplemented:

• ● Application form for an import permit for medical devices
• ● Import order
• ● Import licenses for medical devices
• ● A brief description of the import permit for a medical device

 

 

References:
● Circular 10/2023TT-BYT amending some templates of the Circular 19/2021TT-BYT.