Infrastructure and Medical Device Administration
IMDA- EN
- Infrastructure and Medical Device Administration
- VI
- Cục Hạ tầng và Thiết bị y tế
- JA
- Cục Hạ tầng và Thiết bị y tế（IMDA、医療機器局）
Agency or authority
Definition
The directorate within the Ministry of Health responsible for medical-device regulation in Vietnam — separate from DAV. IMDA was renamed in 2025 from the prior Cục Cơ sở Hạ tầng và Thiết bị y tế and earlier from the Vụ Trang thiết bị và Công trình y tế. It runs the imda.moh.gov.vn portal from 1 January 2025 (legacy dmec.moh.gov.vn ran in parallel through end-2024); issues Class C/D marketing-authorisation certificates and Vietnamese CFS for device exports; and maintains the foreign-manufacturer registry under Decree 98/2021/NĐ-CP as amended.
Sources
- Official portal: https://imda.moh.gov.vn
- Legacy portal: https://dmec.moh.gov.vn
- Legal basis: Nghị định 98/2021/NĐ-CP + Nghị định 07/2023/NĐ-CP + Nghị định 04/2025/NĐ-CP.
See also
- ASEAN Common Submission Dossier Template ASEAN CSDT
- ASEAN Medical Device Directive AMDD
- Certificate of Free Sale (medical devices) CFS
- Drug Administration of Vietnam DAV
- Foreign-invested enterprise FIE
- Free Sale Certificate FSC
- Marketing authorisation / Registration number
- Ministry of Health MOH
- Sở Y tế
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28