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IMDRF - International Medical Device Regulators Forum

What is IMDRF?

IMDRF is the International Medical Device Regulators Forum.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and to accelerate international medical device regulatory harmonization and convergence.

Members of the IMDRF

The current members are:

· Australia (TGA)

· Brazil (ANVISA)

· Canada (HC)

· China (NMPA)

· Europe (EU)

· Japan (PMDA / MHLW)

· Russia (MoH)

· Singapore (HSA)

· South Korea (MFDS) and

· the United States of America (FDA)

IMDRF Adverse Event Terminology Web Browser

The web browser for IMDRF AE terms ensures user-friendly searching and hence better and more adequate use of terms by reporters/regulators.

Global Harmonization Task Force and IMDRF (Implementation of medical device regulations)

The Global Harmonization Task Force (GHTF) was founded in 1993 by the governments and industry representatives of Australia, Canada, Japan, the European Union, and the United States.

The purpose of the GHTF was to encourage convergence in standards and regulatory practices related to the safety, performance and quality of medical devices.

GHTF

GHTF's Mission was to harmonize the implementation of medical device regulations across the globe. In 2011, GHTF's mission was taken over by the IMDRF

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.