What are penalties for circulating medical devices of types B, C, D without registration numbers in Vietnam?

What are penalties for circulating medical devices of types B, C, D without registration numbers in Vietnam? (Illustrative photo)

Decree 117/2020/ND-CP stipulates fines ranging from VND 40,000,000 to VND 50,000,000 for any of the following acts:

- Circulating type A medical devices on the market without a dossier receipt for announced applicable standards or without being issued an import license;

- Circulating type B, C, D medical devices on the market without a registration number or without being issued an import license;

- Circulating medical devices on the market that do not meet the registered quality standards;

- Warranty centers not having the capability to perform warranty services for medical devices as certified by the medical device's owner;

- Failing to temporarily suspend the circulation of medical devices related to incidents that pose a serious threat to public health or cause user fatalities;

- Medical devices that have been issued circulation numbers but continue to be circulated within 24 months from the time the device owner declares cessation of production or goes bankrupt or is dissolved, but the holder of the circulation number in Vietnam does not commit to providing warranty, maintenance, or necessary materials for replacement or use of the medical devices for 8 years, except in cases where the holder of the circulation number is the resident representative office in Vietnam of a foreign trader who owns the medical devices;

- Medical devices that have been issued circulation numbers but continue to be circulated beyond 24 months from the time the device owner declares cessation of production or goes bankrupt or is dissolved.

For detailed penalties, see Decree 117/2020/ND-CP, effective from November 15, 2020.

Ty Na

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