Official Dispatch No. 7165/BYT-TB-CT: includes the following contents:
– Postponing of the valid period for the circulation number of Medical Device B, C, D: The Ministry of Health and the Government have agreed to postpone the valid date until January 1, 2019.
– For Class A Medical device, compliance continues to follow the provisions of Decree 36/2016/ND-CP.
– For domestically manufactured Medical Device, the implementation process continues to be applied according to the regulations in Circular 07/2002/TT-BYT.
– For Class B, C, D Medical Device:
-
- Class B, C, D Medical Device not listed in the Annex of Circular 30/2015/TT-BYT: Comply with Official Letter 3600/BYT-TB-CT.
- Class B, C, D Medical Device listed in the Annex of Circular 30/2015/TT-BYT: Continue to comply with the provisions of Circular 30/2015/TT-BYT until December 31, 2018.
– Regarding the registration of in-vitro diagnostic products, this process continues to be implemented according to the regulations of Circular 44/2014 and Circular 47/2010/TT-BYT.
Readers download the content below:
– English Version: https://medgate.vn/wp-content/uploads/2023/12/EN_7165_BYT-TB-CT.pdf