What are regulations on requirements for medical devices undergoing clinical study in Vietnam?

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Please ask, what are regulations on requirements for medical devices undergoing clinical study in Vietnam? Looking forward to support according to the latest regulations.

According to Article 13 of Decree 98/2021/ND-CP (Effective from 01/01/2022), the requirements for medical devices undergoing clinical study in Vietnam are as follows:

1. The medical device meets quality standards specified in the clinical study application.

2. Technical parameters of the medical device have been duly inspected to ensure its quality and safety.

3. The medical device must be labeled as “for clinical study only - not for any other purposes”. The labeling of medical devices shall comply with regulations of law on labeling of goods.

Best Regards!

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