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.