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Key MOH Circulars (Thông tư)

MOH Circulars (Thông tư) provide the procedural detail that implements the principles set out in Decree 98/2021. They are issued by the Minister of Health and are binding on all regulated entities.

Circular 05/2022/TT-BYT — Import and Export Procedures​

Circular 05/2022/TT-BYT governs the import and export of medical devices, including:

  • Documentation required for import permits (Giấy phép nhập khẩu)
  • Devices that can be imported without a permit (declaration-based import)
  • Special import procedures for clinical investigation devices
  • Import of humanitarian and emergency-use devices
  • Export certificate (CFS) application procedures for Vietnamese-manufactured devices
  • Customs clearance documentation requirements

This Circular works in conjunction with Circular 29/2022 for devices imported for clinical trials.

Circular 29/2022/TT-BYT — Clinical Trial Requirements​

Circular 29/2022/TT-BYT sets out requirements for clinical investigations of medical devices conducted in Vietnam:

  • Requirements for an investigation plan (protocol)
  • Ethics committee approval procedures
  • DAV approval process for investigational device imports
  • Sponsor and investigator responsibilities
  • Adverse event reporting during investigations
  • Post-investigation reporting to DAV
  • GCP requirements for device investigations

Circular 14/2020/TT-BYT — Device Classification Rules​

Circular 14/2020/TT-BYT provides the detailed classification rules for medical devices under the Type A–D framework:

  • Classification rules for non-IVD devices (Rules 1–22 covering duration of use, invasiveness, active device status, anatomical location, etc.)
  • Classification rules for IVD devices (Rules 1–7 based on risk to individual and public health)
  • Procedure for requesting a classification determination from DAV
  • List of devices and their confirmed classifications

This Circular is the primary technical reference for device classification.

Official letters (Công văn)​

In addition to formal Circulars, DAV and MOH issue Official Letters (Công văn) on specific regulatory matters. These are guidance documents, not primary legislation, but they reflect DAV's current interpretation and are practically important for understanding how rules are applied.

Official Letters are typically published on the DAV website (dav.gov.vn) and the DMEC portal announcement section.

Finding current versions​

Always use official Vietnamese government sources for the current, authoritative text of Circulars:

note

Circulars can be amended or replaced. Always verify you are reading the current version, including any amending instruments.