Authorised Representative
The Vietnamese Authorised Representative (Đơn vị bảo lãnh) — who needs one, their responsibilities, and how to appoint them.
Import Licensing
Import permits (Giấy phép nhập khẩu) for medical devices in Vietnam — when they are required, how to apply, and customs clearance.
GDP, Storage & Distribution
Good Distribution Practice (GDP) requirements for medical devices in Vietnam, including storage conditions, cold chain, and distribution records.
The DMEC Portal
Vietnam's National Medical Device Information System (DMEC) — how to register, submit declarations and registrations, and use the portal for post-market activities.