Vietnam’s new regulations on the application for declaration of eligibility for medical device classification

11:02, 17/01/2019

Recently, 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, the establishment conducting the classification of the medical devices must have at least 01 employee that has the practicing certificate. An application for declaration includes:

- The document for declaration of eligibility for medical device classification;

- A list of personnel enclosed with the original copy or certified true copy of the practicing certificate of each person in charge of medical device classification on the list;

- The original copy or certified true copy of the certificate of business registration of the classifying organization or the certificate of investment.

Detailed procedures for declaration of eligibility for medical device classification 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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