Infrastructure and Medical Device Administration
IMDA- EN
- Infrastructure and Medical Device Administration
- VI
- Cục Hạ tầng và Thiết bị y tế
- JA
- 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 Department of Infrastructure and Medical Equipment and earlier from the Department of Medical Equipment and Construction. 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/ND-CP as amended.
Sources
- Official portal: https://imda.moh.gov.vn
- Legacy portal: https://dmec.moh.gov.vn
- Legal basis: Decree 98/2021/ND-CP + Decree 07/2023/ND-CP + Decree 04/2025/ND-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
- provincial Department of Health
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-10-27