Which cases are not allowed to carry out applications for declaration of applied standards for medical devices in Vietnam?

According to Clause 2, Article 23 of Decree 98/2021/ND-CP (Effective from 01/01/2022), the requirements for declaration of applied standards or issuance of certificate of registration for medical devices in Vietnam are as follows:

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;

- If the product owner declares termination of manufacturing of a medical device which has been granted the registration number or goes bankrupt or is dissolved, the medical device may be placed on the market for a maximum period of 24 months from the date of the product owner’s declaration of manufacturing termination, bankruptcy or dissolution provided that the registration number holder in Vietnam provides a commitment to provide warranty or materials for replacing or serving the use of the medical device for 08 years, unless the registration number holder is a permanent representative office in Vietnam of a foreign trader that is the product owner.

b) The medical device is recalled under Clauses 1, 3 Article 38 of this Decree.

- The application for registration number is forged.

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- The applicant deliberately alters or erasures the contents of the registration number.

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Best Regards!