IAF Regions' news

Accredited Conformity Assessment Supporting the Medical Device Sector in the APAC region

Aparna Dhawan
Chair, Communications and Promotion Committee
Asia Pacific Accreditation Cooperation (APAC)

The medical device industry is expanding globally, including in the Asia Pacific region, generating a demand for high-quality and safe products. Conformity assessment and accreditation are key building blocks of a country’s quality infrastructure. Conformity assessment connects requirements set in technical regulations and standards with the products and services that are available to the public. Accreditation provides an additional layer of assurance by verifying and attesting that conformity assessment bodies (CABs) have the competency and impartiality to perform their activities.

Implementation of quality management and accreditation have become essential in the health sector. Many standards are applicable, including ISO 15189, ISO 13485, ISO/IEC 17021, ISO 20387, ISO/IEC 17065 and ISO/IEC 17024. Each economy needs a good regulatory regime, as regulatory issues continue to be a challenge, as well as the implementation of conformity assessment practices to ensure the quality of products and services and support trade. Regulations vary across different economies in the region, creating trade barriers.

In the Asia Pacific region, rules regarding the use of conformity assessment services vary. For instance, Japan, which is widely considered to have the most advanced medical device market, requires manufacturers to comply with the Pharmaceutical and Medical Device (PMD) Act. Compliance to the act is assessed by the Pharmaceutical and Medical Device Agency (PMDA) or registered certification bodies (CBs). The PMD Act allows specific medical devices in the Class II and Class III (low to medium risk) category to quality for designated third party certification. A quality management systems (QMS) certificate must be submitted by the manufacturer.

Similarly, Australia has a highly evolved medical device programme, wherein the Therapeutic Goods Administration (TGA) is responsible for regulating the medical device industry. The need to use CABs has been stipulated by the TGA.  A QMS is required for medical devices Class IIa, IIb, III and active implantable medical devices to get a conformity assessment certificate approved. However, the use of standards is recommended but optional. Australia has its own national standard orders, but the international ISO standards can be used. Standards for QMS (ISO 13485), risk management (ISO 14971), clinical trials (ISO 14155) and biocompatibility (ISO 10993) are recommended depending on the type of medical device.

In Malaysia, the Medical Device Authority under the Ministry of Health is the key regulatory body responsible for the regulation of medical devices in the Malaysian market. The regulation requires Class B to D (low to high risk category) medical devices to be reviewed by CABs.1

In the United States, the Food and Drug Administration (FDA) recently started a pilot program (Accreditation Scheme for Conformity Assessment – ASCA Pilot Program), that links testing laboratories for medical devices, manufacturers and accreditation bodies (ABs). Relying upon international conformity assessment standards and a set of FDA-identified ASCA Pilot specifications, the program is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews.

In other parts of the Asia Pacific region, rules for using conformity assessment services are different for different classes/categories of products. Implementation of different regulatory practices in the region leads to difficulties at the manufacturer’s end while exporting or importing products. To reduce technical barriers to trade, it is critical that a common standardised practice is implemented by the region with respect to conformity assessment requirements.

Harmonisation of quality assurance practices is a pressing need, considering the wide spectrum of requirements across the region and the evolution of the health care sector. Therefore, the way forward is to:

  • Harmonise national standards, technical regulations and conformity assessment requirements across the Asia Pacific region.
  • Implement mutual recognition arrangements (MRAs) of test reports, certifications and conformity.
  • Influence regulators to use services of accredited CABs as per common international standards. Accreditation ensures technical competence, proper implementation of an effective management system, and identifies inherent and other risks.
  • Harmonise the practices of the ABs through the Asia Pacific Accreditation Cooperation (APAC) in the regulatory segment by conducting regular experience exchange workshops and training sessions.

Therefore, APAC is working with stakeholders to ensure harmonisation of best practices is achieved. It is also strengthening the competence of ABs in emerging sectors. An informative webinar was conducted to sensitize and exchange experiences about the requirements of a newly introduced standard under the APAC MRA, ISO 20387. Over 100 participants from various economies in the region attended the sensitization webinar. It has also planned a training session in August 2021 on the requirements of ISO 20387.

APAC is conducting a workshop with regulators in the region on 14 July 2021 in which major international organisations like the World Health Organization and the Testing, Inspection and Certification (TIC) Council will participate and present along with regulators. The purpose of the webinar is to propagate the need for using harmonised regulations across the region and promote trade.

Implementation of a harmonised system of standards, regulations and conformity assessment practices across the region as well as a common understanding of the same by APAC members will support free trade and the assurance of quality in the healthcare industry.

[1] KPMG Consulting. (2020) The Changing Landscape of the Medical Devices Industry in the APAC Region. Retrieved from https://home.kpmg/jp/en/home/insights/2020/05/medical-device-apac.html

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