Vietnam Medtech Regulation: CSDT Applies In 2022 But IVD Industry Wary Of Pharma Influence

Vietnam has adopted the ASEAN Common Submission Dossier Template and updated its medtech regulation to allow more compliance time for medtech manufacturers. But the IVD industry fears too much pharma influence in file auditing.

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Vietnam is making progress in applying the ASEAN Medical Device Directive (AMDD) locally. It cannot yet compare with the likes of Singapore, Malaysia or Indonesia, but it is applying most of the AMDD requirements – some 50-60% for general medical devices, and 60-70% for in vitro diagnostics.

Adding momentum to that, on 15 May the Ministry of Health (MoH) issued the official decision on implementing the AMDD’s Common Submission Dossier Template (CSDT), which will become effective

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