Standard and Conformance

Overview

Trade of products among ASEAN members has been facilitated more than before and products costs are lesser, with the elimination of tariffs. However, there are still non-tariff issues that are delaying products to reach the market. These non-tariff issues include different product specifications, regulations on safety and quality, and the existence of requirements including pre-market approval requirements.


The mandate of eliminating those non-tariff barriers, also known as technical barriers to trade (TBT) is given to the ASEAN Consultative Committee for Standards and Quality (ACCSQ). The ACCSQ was established in to support the realisation of the ASEAN Free Trade Area (AFTA).


The elimination of technical barriers to trade is consistent with international principles such as: (i) transparency/exchange of information, (ii) harmonisation of standards, (iii) mutual recognition arrangements (MRA), (iv) harmonisation of regulatory regimes, and (v) technical cooperation. The initiatives and measures on reducing TBT constituted the realisation of AFTA in 2010, the establishment of the ASEAN Economic Community in December 2015, and towards further integration in line with the ASEAN Vision 2025.

Priority Areas of Cooperation

Harmonisation of standards in ASEAN is governed by the ASEAN Guidelines on Standards, Technical Regulations and Conformity Assessment Procedures (AG-STRACAP), and Guideline on Harmonisation of Standards.  To further achieve free movement of goods and accept conformity assessment results in ASEAN, the ACCSQ adopted the mutual recognition arrangement (MRA) on conformity assessment results thereby removing the duplication of conformity assessment activities (such as testing, inspection or product certification) and facilitate the approval procedures for regulated goods, without compromising the quality of the product and the safety of the consumers.  The development of sectoral MRAs is guided by the following ASEAN documents:

  1. ASEAN Framework Agreement on Mutual Recognition Arrangements;

  2. ASEAN Guidelines for the development of Mutual Recognition Arrangements;

  3. ASEAN Guideline on Conformity Assessment; 

  4. ASEAN Guideline for Sectoral Laboratory Network.

 

The ACCSQ also looks into legal metrology where harmonisation of verification procedures of legal metrology instruments that are used in trade (weighing scales, flow meters, volumetric instruments, among others) are accurate and ensure value for money for the consumers.

 

The scope of eliminating TBT was further expanded and focused in line with the goal of ASEAN Priority Integration Sectors (PIS).  These sectors are:

  1. Agro-Based Products (Prepared Foodstuff – HS Codes 16 to 22);

  2. Automotive;

  3. Healthcare Products,

  1. Cosmetics

  2. Medical Devices

  3. Pharmaceuticals

  4. Traditional Medicines

  5. Health Supplements;

  1. Rubber-Based products;

  2. Electrical and Electronic Equipment;

  3. Building and Construction Materials;

  4. Wood-Based Products, and; 

  5. Digital Trade Standards and Conformance


 

Harmonisation of standards and technical requirements: 


The harmonisation of standards and technical requirements in ASEAN has embarked on the following:

  1. Harmonisation of safety and specification requirements covering electrical and electronic equipment, rubber gloves and condoms and rubber-based products with the relevant international standards such as International Organisation for Standardisation (ISO) and International Electrotechnical Commission (IEC) standards.

  2. Harmonisation of standards/technical requirements for automotive products based on United Nations Economic Commission for Europe (UN) Regulations under the 1958 Agreement. 

  3. Harmonisation of standards on prepared foodstuff products using Codex Alimentarius standards, with focus on food safety aspects, namely: food additives, food contaminants and food contact materials.  Guidelines on Food Control requirements are also being harmonised based on Codex Guidelines.

  4. Harmonisation of technical requirements and drug registration dossier through the implementation of ASEAN Common Technical Requirements (ACTR) and ASEAN Common Technical Dossier (ACTD).  

  5. Harmonisation of standards for medical devices based on ISO standards as well as harmonisation of registration dossier through the adoption and use of ASEAN Common Submission Dossier Template.

  6. Harmonisation of technical requirements for safety, quality and efficacy and product placement requirements of traditional medicines and health supplements (TMHS), including Good Manufacturing Practices Guidelines that also made reference to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guidelines.  

  7. Common procedures on legal metrology such as the ASEAN Common Requirements on Pre-packaged Products and Common Verification Procedures for Non-automatic Weighing Instruments in line with International Organisation of Legal Metrology (OIML) Recommendations. Inter-laboratory comparison (ILC) programs have also been in place where comparison on mass and volume measurement standards had been conducted.


Mutual Recognition Arrangements: 


The general guideline for the development of ASEAN Sectoral Mutual Recognition Arrangements (MRAs) is provided for in the ASEAN Framework Agreement on Mutual Recognition Arrangements where the following MRAs are developed, and with anticipation of other MRAs that are forthcoming.

  1. ASEAN Sectoral MRA for Electrical and Electronic Equipment.  

  2. ASEAN Sectoral MRA for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products.

  3. ASEAN MRA on Bio-Equivalence Study Report of Generic Medicinal Products.

  4. ASEAN Sectoral MRA for Inspection and Certification System on Food Hygiene for Prepared Foodstuff Product



Harmonisation of Regulatory Regimes: 


Going beyond harmonisation of standards and technical requirements and MRAs, the ASEAN has also embarked on harmonising its regulatory regimes to establish a coherent and unified regulatory systems in the region.  


The development of regulations of the AMS is guided by the ASEAN Good Regulatory Practice (GRP) Guide and the ASEAN General Principles on Harmonisation of Regulatory Regimes.   


Three product sectors have undertaken this initiative:

  1. Cosmetics, through the Agreement on ASEAN Harmonised Cosmetic Regulatory Scheme, signed in 2003.  

  2. Electrical and Electronic Equipment under the Agreement on the ASEAN Harmonised Electrical and Electronic Equipment Regulatory Regime, signed in 2005. 

  3. Medical Devices with the Agreement on ASEAN Medical Device Directive, signed in 2014.

ASEAN Standards and Conformance Startegic Plan 2016-2025

In line with the ASEAN Vision 2025, a ten-year strategic plan on standards, technical regulations and conformity assessment procedure, including legal metrology, was developed in 2016 and has been the guiding chart of ASEAN in continuously eliminating technical barriers to trade.  

 

Major Committees and Sectoral Bodies

 

The ACCSQ is structured to support the integration of these sectors while reporting its progress to higher ASEAN bodies, as shown in the structure below.  The ACCSQ also serves as a consultative platform for relevant stakeholders to discuss issues related to standards, technical regulation, conformity assessments and legal metrology.  

The ACCSQ comprise of the heads of national standards bodies of the ASEAN Member States that meets at least once a year.   The Contact Points of the members of the ACCSQ and the Schedule of Meetings of the ACCSQ and its working groups (WG) and product working groups (PWG) are available in the link provided.

 

Cooperation with Partners/Industry

 

The cooperation on standards and conformance go beyond ASEAN.  The same principle on TBT elimination to facilitate trade is extended to the ASEAN partners under the specific chapter of the existing ASEAN Free Trade Agreements.   

 

The following are the existing committee under the existing FTA chapter on TBT:

 

  1. ASEAN, Australia and New Zealand Free Trade Area (AANZFTA), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures. 
  2. ASEAN China Free Trade Area (ACFTA), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures.
  3. ASEAN-Japan Comprehensive Economic Partnership Agreement (AJCEP), Sub-Committee on Standards, Technical Regulations and Conformity Assessment Procedures. 

  4. ASEAN-Korea Free Trade Agreement (AKFTA), Working Group on Technical Barriers to Trade (TBT) and Sanitary and Phyto-sanitary measures (SPS).  

  5. ASEAN-Hong Kong Free Trade Area (AHKFTA)– Chapter on Standards, Technical Regulations and Conformity Assessment Procedures.

  6. Regional Comprehensive Economic Partnership Agreement (RCEP), Chapter on Standards, Technical Regulations and Conformity Assessment Procedures. 

 

Cooperation or engagement with the industry association associated with ASEAN is undertaken through the relevant product working groups.  The guide on engagement with the industry is   guided by the ASEAN Rules and Procedures on Private Sector Engagement. 

AGREEMENTS

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)

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