Vietnam: When shall the medical device classification certificate be revoked?

09:20, 15/01/2019

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

According to Decree No. 169/2018/ND-CP of Vietnam’s Government, there are 05 cases of revocation of the medical device classification certificate (hereinafter referred to as “practicing certificate”), specifically as follows:

- Use of fraudulent documents in the application for the practicing certificate;

- Carrying out medical device classification without satisfying the conditions;

- Carrying out medical device classification and issuing classification results while the certificate of training in medical device classification has expired;

- Giving an incorrect classification result that reduces the level of risk of the medical device for the second time within 12 months;

- Carrying out medical device classification and issuing classification results while being suspended, including the case in which the classifying organization employing the person is suspended or has the certification of eligibility declaration revoked.

Procedures for revocation of a practicing certificate 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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