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Vietnam in the ASEAN Regulatory Landscape

Vietnam is a founding and active member of the Association of Southeast Asian Nations (ASEAN) and participates in ASEAN's medical device regulatory harmonisation programme under the ASEAN Medical Device Directive (AMDD).

ASEAN medical device harmonisation​

The ASEAN AMDD, developed by the ASEAN Consultative Committee for Standards and Quality — Medical Device Product Working Group (ACCSQ-MDPWG), aims to harmonise medical device regulation across the 10 ASEAN member states. Key harmonised elements include:

  • Classification framework — Type A–D system adopted across ASEAN member states (though implementation timelines and procedural details vary by country)
  • Common Submission Dossier Template (CSDT) — a standardised dossier format accepted across ASEAN, reducing the burden of preparing separate dossiers for each country
  • Essential Principles of Safety and Performance — harmonised performance requirements aligned with IMDRF/GHTF guidance
  • Post-market surveillance obligations — harmonised vigilance and recall reporting expectations

Vietnam's ASEAN implementation​

Vietnam has implemented the AMDD framework through Decree 98/2021 and its supporting Circulars. The classification rules, CSDT structure, and Essential Principles in Vietnam are directly derived from ASEAN harmonised documents.

ASEAN member state comparison​

CountryRegulatorClassificationSubmission system
VietnamMOH/DAVType A–D (AMDD)DMEC portal
SingaporeHSAClass A–D (AMDD)PRISM portal
MalaysiaMDAClass A–D (AMDD)MyMDA portal
IndonesiaBPOM/KemenkesClass A–D (AMDD)Regalkes portal
ThailandFDA ThailandClass 1–3 (similar)e-Submission
PhilippinesFDA PhilippinesClass A–D (AMDD)eDRLS

ASEAN as a multi-market strategy​

ASEAN harmonisation means that regulatory materials prepared for one ASEAN market can often be leveraged for other ASEAN submissions. In particular:

  • A CSDT prepared for a Singapore HSA registration can be adapted for a Vietnamese Type C/D application with localisation
  • CFS documents obtained for one ASEAN country can be used for others (subject to current requirements)
  • Clinical evidence accepted in one ASEAN jurisdiction is generally acceptable in others

IMDRF membership​

Vietnam participates in the International Medical Device Regulators Forum (IMDRF) as an affiliate member. IMDRF guidance documents (on clinical evidence, SaMD, UDI, and other topics) inform DAV's regulatory approach, even where formal adoption has not occurred.

What harmonisation means in practice​

Despite harmonisation progress, material differences remain between ASEAN member states in:

  • Specific procedural requirements (e.g. legalisation requirements for CFS vary significantly)
  • Review timelines
  • Fees
  • Language requirements
  • Enforcement culture and inspection frequency

Always verify current country-specific requirements rather than assuming full harmonisation.