Market Access

Asean Countries

Medical Device Registration in ASEAN Countries

Seamless Market Entry with AQC

Expanding into the Association of Southeast Asian Nations (ASEAN) market requires compliance with local medical device regulations while navigating different approval processes in each country. At AQC, we specialize in medical device (MD) and in vitro diagnostic (IVD) registrations across ASEAN member states, ensuring manufacturers achieve regulatory approvals efficiently and in compliance with the latest standards.

Regulatory Framework: ASEAN Medical Device Directive (AMDD)

To harmonize regulations within the region, ASEAN introduced the ASEAN Medical Device Directive (AMDD), which aligns medical device registration procedures among its member states. Countries that have adopted AMDD follow a risk-based classification system and Common Submission Dossier Template (CSDT) for regulatory submissions.

Our team helps manufacturers leverage ASEAN harmonization for faster approvals while ensuring compliance with country-specific requirements.

ASEAN Countries We Cover

  • Singapore – Health Sciences Authority (HSA)
  • Malaysia – Medical Device Authority (MDA)
  • Indonesia – Ministry of Health (MOH RI)
  • Thailand – Thai Food and Drug Administration (Thai FDA)
  • Vietnam – Ministry of Health (MOH)
  • Philippines – Food and Drug Administration (FDA)
  • Brunei – Ministry of Health (MOH)
  • Myanmar – Food and Drug Administration (Myanmar FDA)
  • Cambodia – Ministry of Health (MOH)
  • Laos – Ministry of Health (MOH)

Our ASEAN Medical Device Registration Services

Product Classification & Registration Strategy

  • Determine the correct device classification (Class A, B, C, or D)
  • Identify the registration process and approval timelines for each country
  • Ensure compliance with AMDD requirements & local regulations

Technical Documentation Preparation (CSDT & STED Format)

  • Prepare the Common Submission Dossier Template (CSDT) as per ASEAN guidelines
  • Assist with clinical data, risk management (ISO 14971), and performance evaluation reports
  • Ensure compliance with ISO 13485, GSPR, and QMS requirements

Local Authorized Representative Services

  • Provide in-country representation for manufacturers without a local office
  • Act as a regulatory liaison with national health authorities
  • Manage post-market compliance and regulatory updates

Fast-Track Registration & Mutual Recognition Agreements (MRA)

  • Utilize ASEAN Mutual Recognition Arrangements (MRAs) for streamlined approvals
  • Support manufacturers in leveraging Singapore HSA or Malaysia MDA approvals for faster entry into other ASEAN markets
  • Guide through special approval pathways for priority devices

Post-Market Compliance & Renewals

  • Assist with adverse event reporting, recalls, and regulatory updates
  • Support in post-market surveillance (PMS), periodic safety updates, and renewal processes
  • Ensure compliance with Good Distribution Practices for Medical Devices (GDPMD)
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