International Medical Device Regulators Forum (IMDRF)
IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work established by the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.
IMDRF was established in October 2011, by representative from the following listed countries and organizations; United States, Australia, Brazil, Canada, China, European Union, Japan and the World Health Organization (WHO).
The 2024 IMDRF Chair and Secretariat is held and led by
United States of America
IMDRF is comprised of Management Committee Members, Official Observers, Affiliate Members and Regional Harmonization Initiatives.
IMDRF has also established a number of working groups to address pressing issues with the realm of medical device regulation and submissions. Working groups develop technical documentation and discuss best practice within the industry.
Please see current list of IMDRF Working Groups.
Please see current IMDRF developed Technical Documents.
Please see current IMDRF developed Information Documents.
Please see current IMDRF session Outcomes Statements.