What are regulations on registration number of medical devices in Vietnam?
Please ask, what are regulations on registration number of medical devices in Vietnam? Looking forward to support under the new regulations.
According to Article 21 of Decree 98/2021/ND-CP (Effective from 01/01/2022), regulations on the registration number of medical devices in Vietnam are as follows:
1. Registration number of a medical device is:
a) The number of declaration of applied standards of Class-A or Class-B medical device;
b) The number of certificate of registration of Class-C or Class-D medical device.
2. Registration number holder is the organization that declares applied standards for Class-A or Class-B medical device or that is granted certificate of registration of Class-C or Class-D medical device.
3. Validity of registration number: The medical device registration number shall be valid for indefinite term, except cases where a registration number is issued according to regulations on issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes. Based on the application for issuance of emergency use registration number for the medical device, the Minister of Health shall decide specific period validity of the issued registration number.
Best Regards!
