ASEAN Common Submission Dossier Template

The standardised dossier format adopted across ASEAN member states for medical-device registration. In Vietnam, ASEAN CSDT has been mandatory for Class C/D medical-device registration dossiers since January 2024, aligning with the ASEAN Medical Device Directive (AMDD) harmonisation framework. Filing under CSDT is required whether the device follows the standard pathway or the Reference-Country fast-track. Templates and guidance live in Circular 19/2021/TT-BYT as amended by Circular 10/2023/TT-BYT.

• Thông tư 19/2021/TT-BYT + Thông tư 10/2023/TT-BYT.
• Legal basis: Nghị định 98/2021/NĐ-CP and amendments.