Posted 25 October 2012 | By Alexander Gaffney, RAC, 

Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity

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The Asian Harmonization Working Party (AHWP), a standards harmonization group focused on medical devices, has released a strategic framework and two proposed standards for public comment.

The group, established in 1999, includes 23 countries across Asia, Latin America and the Middle East and now considers itself the, "Largest medical device regulatory harmonization body in the world."

The group's forward-looking strategic framework, which it bills as the "Strategic Frame Work Towards 2020," aims to increase its membership by focusing on additional economies.

"Given the rising wave of interest in international and cross-regional collaboration and harmonization of medical device  regulation, AHWP should reach out to non-member economies and form alliances with economies and associations across the globe," it explains in the report. Countries with developing regulatory systems-even "rudimentary" ones-will be welcomed into the organization.

Because of the smaller size of most economies and regulatory systems involved in the AHWP, it said much of its future efforts will be focused on training regulators and building regulatory capacity by partnering with other regulatory bodies and regulatory-focused organizations and non-profits such as the World Health Organization, the Asia-Pacific Economic Cooperation (APEC) and the Regulatory Affairs Professionals Society (RAPS). [Full disclosure: Regulatory Focus is a publication of RAPS. - Ed.]

AHWP also explained that it is looking to adopt or adapt the current regulatory harmonization model used by the Global Harmonization Task Force (GHTF)-currently disbanding in favor of the International Medical Device Regulators Forum (IMDRF)-to construct regulatory systems across its member economies using shared guidance and definitions.

AHWP cited medical devices, manufacturers and importers as terms that could stand to benefit from shared regulatory definitions, and also said they were looking at standards for risk-based classification of devices and shared postmarket adverse event surveillance systems.

Two standards were also released by AHWP: one proposing a standardized definition and classification for field corrective actions, and another proposing a standardized medical device adverse event re

porting form. Comments on both documents are due by 31 October 2012. (FCA) (MDAE), while comments on AHWP's strategic framework are due by 4 February 2012.