ASEAN Common Submission Dossier Template (CSDT)
ASEAN CSDT — Common Submission Dossier Template (Medical Devices)
- EN
- ASEAN CSDT — Common Submission Dossier Template (Medical Devices)
- VI
- Mẫu hồ sơ ASEAN CSDT — đăng ký trang thiết bị y tế
- JA
- ASEAN CSDT — 医療機器共通申請書類テンプレート
Medical device
https://imda.moh.gov.vn
Description
The ASEAN Common Submission Dossier Template (CSDT) is mandatory for Class C and Class D medical-device registration dossiers filed with IMDA from January 2024. Standard pathway and Reference-Country fast-track both require CSDT format.
Legal basis
Circular 19/2021/TT-BYT (amended by Circular 10/2023/TT-BYT). Decree 98/2021/NĐ-CP (amended by Decrees 07/2023 and 04/2025).
- Issuing authority
- IMDA (Cục Hạ tầng và Thiết bị y tế), MOH
- Format
- PDF + Word
- Submission
- Online via imda.moh.gov.vn
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28