With the implementation of the revised Medical Device Management Enforcement Decree (98/2021/ND-CP) in 2021, Vietnam (MoH) extended the registration expiration date for Class C and D medical devices by one year to December 31, 2022, and made distribution registration mandatory from 2022. However, during that period, companies experienced a lot of inconvenience and confusion as the Ministry of Health's medical device registration process did not proceed normally.
As a result, the Vietnamese Ministry of Health's enforcement decree re-extends the validity of the import license and registration of Class C and D medical devices due on December 31, 2022 by two years to December 31, 2024 due to the revision of 98/2021/ND-CP, and delays the implementation of the ASEAN Standard Technical Document (CSDT) to January 2024.
CSDT(Common Submission Dossier Template) is a common template for medical device manufacturers looking to enter the ASEAN market.
In other words, the application requirement for all new Class C,D for submission to the Ministry of Health (MoH) of Vietnam requires submission in Vietnamese IFU and CSDT formats.
Vietnam's Ministry of Health has not yet issued official guidelines regarding the contents of the CSDT, However, the CSDT draft can be found in the file below.
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