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 the following new Affiliate Members:

  • DNM, El Salvador

  • EFDA, Ethiopia

  • JFDA, Jordan

  • PPB, Kenya

  • COFEPRIS, Mexico

  • NAFDAC, Nigeria

  • TMDA, Tanzania

Contacts will be available on the Affiliate Membership page as they become available.

Presentations and the Outcome Statement from the 25th IMDRF Management Committee Session held in March 2024 in Washington DC are available here.

Following from the virtual Management Committee meeting in June, the 26th Session will be held in Seattle, Washington from 16 to 20 September 2024. More details will be available soon.

The 2024 IMDRF Chair and Secretariat is held by the United States of America. 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.

Working groups

Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.

Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.

Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.

Latest documents