Decision No. 2426/QD-BYT dated May 15th, 2021 of the Ministry of Health on promulgation of guidance on the preparation of Asean common submission dossier for medical devices

This Decision promulgates the ASEAN Common Submission Dossier Template (CSDT) for medical devices, applied to applications for registration of medical devices of class B, C, D.

Accordingly, the common submission dossier for medical devices must fully have these contents:

1. Overview about the medical device

2. Essential Principles Conformity Checklist

3. Medical device description

4. Summary of Design Verification and Validation Documents

5. Medical Device Labelling

6. Risk Analysis

7. Manufacturing Information

This Decision comes into force as of its date of promulgation.