Medical device registration / số lưu hành
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 Sở Y tế of the registration holder. Lower regulatory burden than Class C/D registration; the số lưu hành is issued by Sở Y tế rather than by IMDA.
Legal basis
Decree 98/2021/NĐ-CP Article 26 (amended). Circular 05/2022/TT-BYT (classification rules).
- Issuing authority
- Sở Y tế (provincial Department of Health)
- Format
- Online form (portal submission)
- Submission
- Online via MOH portal / Sở Y tế
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28