Rights and obligations of medical device trading establishments in Vietnam

What are regulations on rights of medical device trading establishments in Vietnam?

According to Article 51 of Decree No. 98/2021/ND-CP stipulating rights of medical device trading establishments, specifically:

1. Request the medical device seller to provide adequate information and documents serving the tracing of origin and warranty on the medical device.

2. Request importers, distributors and users to cooperate in recalling and handling defective medical devices.

3. Request the registration number holder or warranty center that is recognized by the product owner to provide warranty on the medical device.

4. Receive notice of defective medical device from the registration number holder.

5. Exercise other rights as prescribed by laws.

What are obligations of medical device trading establishments in Vietnam?

According to Article 52 of Decree No. 98/2021/ND-CP stipulating obligations of medical device trading establishments, specifically:

1. Implement internal control measures to maintain the quality of medical devices as prescribed by the registration number holder.

2. Provide users with adequate and timely information about:

a) Instructions for use of medical devices; conditions for ensuring safety, storage, calibration, inspection and maintenance of medical devices;

b) Notices of defective medical devices.

3. Declare and post medical device prices in accordance with regulations of law. Do not trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading.

4. Keep documents on management of medical devices and carry out tracing of origin and recall of medical devices in accordance with regulations of this Decree.

5. Promptly notify registration number holders and state regulatory authorities of defective medical devices.

6. Comply with regulations of law and inspection decisions issued by competent authorities.

7. Perform other obligations as prescribed by law.

Best Regards!