Vietnam: What are the conditions for a person to be granted the medical device classification certificate?

According to Decree No. 169/2018/ND-CP of Vietnam’s Government, a person will be granted the medical device classification certificate (hereinafter referred to as “practicing certificate”) if he/she:

- has at least a bachelor’s degree in technology, health or pharmacy;

- has at least 24 month’s experience of working with medical devices within the last 48 months before the application date; and

- has completed the Ministry of Health’s training course in classification of medical devices at a qualified health facility.

Besides, an application for issuance of a new practicing certificate consists of

- The application form;

- The original copy or certified true copy of the applicant’s degree in technology, health or pharmacy;

- The original copy or certified true copy of an unexpired certificate of training in medical device classification (not exceeding 03 years from the day on which it is signed);

- Two color 4x6 cm picture on a white background taken in the last 6 months;

- The original copy or certified true copy of the applicant ID card or passport;

- The original copy or copy of the confirmation of working duration. If the applicant works for multiple classifying organizations and the duration of working for each classifying organization is less than 24 months, he/she shall obtain the confirmation of working duration from each classifying organization to prove his/her experience.

Procedures for issuance of a new 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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