Vietnam: MOH has issued Circulars 05/2022/TT-BYT on new update for Class C and D Applications

Vietnam MOH has issued Circulars 05/2022/TT-BYT which is a detail guides of some articles in Decree 98. We would like to update to you Article 3 of this circulars because it is our good news.

Article 3 of Circulars 5 in summary is below:

Class C, D Application need not require local evaluation of the product in 3 following cases:

+ Products have been granted a Certificate of Free Sale (CFS/CFG) of one of reference countries (USA; Australia; Health Canada; Japan, EU member states, China, Korean).

+ Products have been licensed under CL 30 or CL 47 in Viet Nam.

+ Products are not reagent, calibrator, control.

Source:

Thông tư 05/2022/TT-BYT quy định chi tiết một số điều của Nghị định 98/2021/NĐ-CP (luatvietnam.vn)

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