Medical device registration number
Class A/B Medical Device Self-Declaration of Conformity
- EN
- Class A/B Medical Device Self-Declaration of Conformity
- VI
- Công bố tiêu chuẩn áp dụng cho trang thiết bị y tế Class A/B
- JA
- Class A/B 医療機器の適合自己宣言
Medical device
https://imda.moh.gov.vn
Description
Self-declaration of conformity for Class A and Class B medical devices, filed with the provincial Department of Health of the registration holder. Lower regulatory burden than Class C/D registration; the registration number is issued by provincial Department of Health rather than by IMDA.
Legal basis
Decree 98/2021/ND-CP Article 26 (amended). Circular 05/2022/TT-BYT (classification rules).
- Issuing authority
- provincial Department of Health
- Format
- Online form (portal submission)
- Submission
- Online via MOH portal / provincial Department of Health
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-10-27