Marketing authorisation / Registration number

The umbrella term for the authorisation a regulated product must hold before commercial sale in Vietnam. For drugs, the marketing authorisation (giấy đăng ký lưu hành thuốc) is indexed by số đăng ký (SĐK / VN-…) issued by DAV under Circular 12/2025/TT-BYT (or Circular 29/2025 for traditional medicines). For medical devices, số lưu hành is issued by Sở Y tế (Class A/B via self-declaration) or by IMDA (Class C/D, including the Reference-Country fast-track) under Decree 98/2021/NĐ-CP. The number is presented at customs for ordinary commercial import.

• Drugs: Thông tư 12/2025/TT-BYT.
• Traditional medicine: Thông tư 29/2025/TT-BYT.
• Medical devices: Nghị định 98/2021/NĐ-CP + amendments.