1. ASEAN Agreement on Medical Device Directive (2014)

  • Interpretative Notes for AMDD
  • Annex 1: Essential Principles of Safety and Performance of Medical Devices
  • Annex 2: Risk Classification Rules for Medical Devices other than IVD Medical Devices
  • Annex 3: Risk Classification Rules for IVD Medical Devices
  • Annex 4: ASEAN Common Submission Dossier Template
  • Annex 5: Post Marketing Alert System (PMAS) Requirements
  • Annex 6: Components Elements of a Product Owner’s or Physical Manufacturers’ Declaration of Conformity (DOC)
  • Annex 7: Labelling Requirements
  • Annex 8: Clinical Investigation
    • Member States Regulation
      • Singapore Regulations on Medical Device

2. Agreement on the ASEAN Harmonized Electrical and Electronic Equipment (EEE) Regulatory Regime (2005)

3. Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme (2003)

4. ASEAN Food Safety Regulatory Framework (2016)