Vietnam: 07 cases of suspension of medical device classification activities

14:21, 17/01/2019

This is a featured content of Decree No. 169/2018/ND-CP of Vietnam’s Government 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, a classifying organization shall be suspended from medical device classification if it:

- carries out medical device classification before submitting the declaration of eligibility for medical device classification;

- uses untruthful or inaccurate documents to declare eligibility for medical device classification;

- fails to satisfy the conditions;

- gives an incorrect classification result that reduces the level of risk of the medical device;

- gives a classification result without signature of the person stated on the certification of eligibility declaration or the classifying organization’s legal representative;

- fails to implement or satisfactorily implement the remedial measures as requested by the supervisory body;

- fails to publish the classification results.

Procedures for suspension 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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