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U.S. Department of Health and Human Services

Medical Devices

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International Medical Device Regulators Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) disclaimer icon is a voluntary group of medical device regulators from around the world, including FDA, who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices. The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence. Member countries rotate the role of IMDRF Chair, and the US FDA will assume this role in 2014.

The current IMDRF regulatory members are: Australia, Brazil, Canada, China, Europe, Japan, Russia, and the U.S. The World Health Organization (WHO) is an official observer. The Asian Harmonization Working Party and APEC’s Life Sciences Innovation Forum’s Regulatory Harmonization Steering Committee are both affiliate organizations with IMDRF.