Introduction to the article on conformity assessment
for the medical device sector by the IAF

The IAF published an article on Medical Device Conformity Assessment in Asia Pacific on July 2, 2021 under the title of “Accredited Conformity Assessment Supporting the Medical Device Sector in the APAC region”.

To summarize, the demand for high-quality and safe products is increasing as the medical device industry expands around the world, including in the Asia Pacific region.

Conformity assessment connects requirements set in technical regulations and standards with the products and services that are available to the public.

A good regulatory framework is required to ensure the quality of products and services and to implement conformity assessment to support trade, and this varies by country and community.

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In the Asia Pacific region, the conformity assessment services also vary. This article provides a brief introduction to regulations in Japan, Malaysia, Australia and the United States.

Medical device regulations in the Asia-Pacific region are various, so it makes difficult for manufacturers to export or import products to trade.

Therefore, to reduce technical barriers to trade, it is said that it is important to implement harmonized standards in the region with respect to conformity assessment requirements.

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Accordingly, APAC, the regional accreditation group of the IAF, held a webinar on the newly introduced standard according to ISO 20387(General requirements for biobanking).

On July 14, APAC also held a workshop with the World Health Organization and the TIC (Testing, Inspection and Certification) Committee to discuss policies to promote trade and the use of harmonized standards across the region.

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