International Medical Device Regulators Forum (IMDRF)
We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety.
Learn more about us through this short video
At the March Meeting, the IMDRF Management Committee welcomed Swissmedic (Swiss Agency for Therapeutic Products – Switzerland) as an IMDRF Management Committee Member.
The Management Committee also welcomed the following new Affiliate Members:
Medical Device Authority (MDA) - Malaysia
The Center for Pharmaceutical Products Safety - Uzbekistan
Zanzibar Food and Drug Agency (ZFDA) – Tanzania.
Contacts will be found on the Official Observer and Affiliate Membership pages as they become available.
Presentations and the Outcome Statement from the 27th IMDRF Management Committee Session held in March 2025 in Tokyo, Japan will be available under Meetings when finalized.
The 2025 IMDRF Chair and Secretariat is held by Japan. Upcoming rotations of the Chair and Secretariat can be viewed here.
The impact of COVID-19
The International Medical Device Regulators Forum (IMDRF) acknowledges the significant impact of the COVID-19 pandemic on all countries and citizens. The use of essential medical devices such as ventilators, oxygen concentrators, syringes and test kits contributed to the efforts of pandemic responses around the world, as with other products regulated in some countries such as surgical face masks.
The IMDRF held a Joint Workshop on COVID-19 in March 2021 and held regular discussions about the impacts, experiences and challenges during the pandemic. Members continue to share information about changes made to regulatory frameworks that aim to assist preparations for future pandemics. Some of these included emergency use or other systems to expedite access and supply of essential medical devices, flexible and pragmatic approaches to regulatory processes such as remote inspections, and publishing information about approval pathways and availability of critical medical devices.
A link to each member country's website is below, where you can find more detailed information.