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 is indexed by registration number issued by DAV under Circular 12/2025/TT-BYT (or Circular 29/2025 for traditional medicines). For medical devices, registration number is issued by provincial Department of Health (Class A/B via self-declaration) or by IMDA (Class C/D, including the Reference-Country fast-track) under Decree 98/2021/ND-CP. The number is presented at customs for ordinary commercial import.

• Drugs: Circular 12/2025/TT-BYT (to be replaced by Circular 32/2026/TT-BYT from 01/10/2026 — see /regulations/#tt-32-2026).
• Traditional medicine: Circular 29/2025/TT-BYT.
• Medical devices: Decree 98/2021/ND-CP + amendments.