Please ask, what are regulations on requirements for declaration of issuance of certificate of registration for medical devices in Vietnam? Looking forward to support under the new regulations.
According to Article 23 of Decree 98/2021/ND-CP (Effective January 1, 2022), the requirements for declaration of applied standards or issuance of certificate of registration for medical devices in Vietnam are as follows:
1. Requirements for declaration of applied standards or issuance of certificate of registration for medical devices:
a) The medical device is manufactured domestically by a manufacturer that has made declaration of eligibility for manufacture of medical devices;
b) If the medical device is imported, it has been manufactured by a manufacturer that is granted certificate of conformity with ISO 13485 quality control standards, and permitted to be sold in every country in the world;
c) The medical device comply with national technical regulations or standards declared by the manufacturer.
2. Applications for declaration of applied standards or registration of medical devices shall be rejected in the following cases:
a) The medical device falls in the case specified in Clause 1 Article 37 of this Decree;
b) The medical device is recalled under Clauses 1, 3 Article 38 of this Decree.
3. If a medical device registration number is revoked under Clause 2 Article 38 of this Decree, an application for declaration of applied standards or registration of that medical device submitted within 12 months from the date of the revocation decision shall be rejected.
Best Regards!