Vietnam: Methods of registration of medical equipment

08:58, 05/01/2019

At the end of 2018, the Government of Vietnam issued Decree No. 169/2018/ND-CP on amendments to Decree No. 36/2016/ND-CP on medical equipment management.

Issuance of a new registration number

According to Vietnam’s new regulations, a new registration number shall be issued in the following cases:

- The medical device has not had any registration number;

- The in vitro diagnostic device or disposable medical device already has a registration number but there is a change in its category or materials that affect its function.

- The existing registration number of the medical device is not renewed by the deadline mentioned in Clause 3 Article 27 of Decree No. 36/2016/ND-CP of Vietnam’s Government.

Quick issuance of a new registration number

- The medical device has been placed on the market in at least 02 of the following countries: Japan, Canada, Australia, EU member states;

- The medical device has placed on the market in Vietnam before December 31, 2018 and satisfies the following conditions:

+ It has been placed on the market for at least 03 years in the last 05 years before the application date;

+ There is no warning against its quality and safety.

Renewal of registration numbers shall apply in cases where the registration number is about to expire.

Relevant provisions can be found in Decree No. 169/2018/ND-CP of Vietnam’s Government, which takes effect from December 31, 2018.

- Thanh Lam -

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