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)

• Appendix A: Terminology
• Appendix B: ASEAN Essential Requirements for Regulated EEE
• Appendix C: ASEAN Harmonized Conformity Assessment Procedure for EEE
• Appendix D: Technical Files
  • List of Harmonised International Standards and Regulatory Requirements
  • Risk Assessment Guidelines on EEE
  • Consolidated Regulatory regime of EEE of the ASEAN Member States
    • Updated Regulatory Regime of Cambodia, July 2012
    • Updated Regulatory Regime of Indonesia, Feb 2023
    • Updated Regulatory Regime of Malaysia, Sep 2023
    • Updated Regulatory Regime of Myanmar, February 2016
    • Updated Regulatory Regime of Philippines – approved IRR of DAO 3 on LVE
    • Updated Regulatory Regime of Philippines , March 2016
    • Updated Regulatory Regime of Singapore, August 2025
    • Updated Regulatory Regime of Thailand, Oct 2023
      
    • Updated Regulatory Regime of Viet Nam , May 2016

• Survey on Technical Infrastructure on Electrical and Electronic Products in ASEAN
• Information Booklet on AHEEERR
• List of Additional Requirements and Critical Interpretation
• Contact Points

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

• ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics
• ASEAN Cosmetic Ingredient Listing
• ASEAN Handbook of Cosmetic Ingredients
• ASEAN Cosmetic Good Manufacturing Practices
  • FAQ on the Interpretation on ASEAN GMP Guideline for Cosmetic
  • ASEAN Cosmetic Good Manufacturing Practice (GMP) Training Modules
    (i) Contract Manufacturing
    (ii) Documentation
    (iii) Equipment
    (iv) Internal Quality Audit
    (v) Personnel
    (vi) Premises
    (vii) Product Complaint
    (viii) Production
    (ix) Quality Control
    (x) Quality Management
    (xi) Recall
    (xii) Sanitation and Hygiene
    (xiii) Storage
    (xiv) Inspection

• ASEAN Definition of Cosmetics and Illustrative List by Category of Cosmetic Products
  • Appendix I – Illustrative List of Cosmetic Products by Categories
  • Appendix II – ASEAN Cosmetic Labeling Requirements
  • Appendix III – ASEAN Cosmetic Claim Guideline
  • Appendix VI – ASEAN Guidelines for Cosmetic GMP
• ASEAN Cosmetic Product Information File (PIF)
  • Guidelines for PIF
• ASEAN Cosmetic Notification
  • Guidance on Product Notification to the Regulatory Authority
  • FAQ on the Interpretation on Cosmetic Product Notification
• ASEAN Cosmetic Safety Assessment
  • Guidelines for Safety Assessment of a Cosmetic Product
• ASEAN Botanical Safety Assessment Guideline
• A Guide Manual for Adverse Event Reporting
• ASEAN Guidelines on Limits of Contaminants for Cosmetics
• ASEAN Sunscreen Labelling Guideline
• General Information Booklet on ASEAN Harmonized Cosmetic Regulation Scheme
• ASEAN Consumer Information Handbook on Cosmetic Product
• ASEAN Accredited Cosmetic Laboratories
• ASEAN Cosmetic Harmonized Testing Method to Support the Post Marketing Surveillance (ASEAN Cosmetic Method/ACM)
• Q&A on Specific Provisions of the ASEAN Cosmetic Directive (ACD)
• Compulsory Documents/Template for the Implementation of ACD
  • Notification
  • Report for Adverse Cosmetic Event
• Reference Documents for the Implementation of ACD
  • ASEAN Microbiological Test Limits
  • Contact Points
• Joint Opinion Statements (JOS) for Talc

• ASEAN Cosmetic Committee (ACC) Statement on Antimony in Cosmetics

• ASEAN Cosmetic Committee (ACC) Statement on Parabens

4. ASEAN Food Safety Regulatory Framework (2016)

1. ASEAN Framework Agreement on Mutual Recognition Arrangements (1998)

ASEAN Framework Agreement on Mutual Recognition Arrangements (2017)

• Interpretative Notes of ASEAN Framework Agreement on Mutual Recognition Arrangements
• Guidelines for the Development of Mutual Recognition Arrangements
• Guidelines for the Development of Mutual Recognition Arrangements (2018)
• What is MRA and how it is expected to help industry in the region?

2. ASEAN Sectoral Mutual Recognition Arrangement for Electrical  and Electronic Equipment (2002)

• FAQ on ASEAN Sectoral MRA for Electrical & Electronic Equipment (ASEAN EE MRA)
• Criteria for being designated as Testing Laboratories or Certification Bodies for the Implementation of the Sectoral MRA
• Listing of Testing Laboratories and Certification Bodies for the ASEAN EE MRA

3. ASEAN Sectoral Mutual Recognition Arrangement for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products

• Protocol to Amend ASEAN Sectoral Mutual Recognition Arrangement for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products (Protocol to Amend MRA for GMP)
• 15 FAQs on the ASEAN MRA for GMP
• Listed Inspection Service under ASEAN MRA for GMP

4. ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff

• Annex 1 and Annex 2 of the ASEAN MRA for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff 

1. Memorandum of Cooperation between the Department of Commerce of the United States of America and the ASEAN Secretariat (2001)

2. The Memorandum of Understanding on Standards and Quality (1996)

3. Memorandum of Understanding on Standstill and Rollback on Non-Tariff Barriers among ASEAN Countries (1987)