Standard and Conformance

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.

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