Please ask, which cases are not allowed to carry out applications for declaration of registration of medical devices in Vietnam? Looking forward to support under the new regulations.
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!