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.

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The IMDRF Management Committee welcomes AMDF (African Medical Device Forum) as a new Regional Harmonisation Initiative and six new affiliate members:

  • CECMED (Cuba)

  • CinMED (Montenegro)

  • EDA (Egypt)

  • ISP (Chile)

  • MTIIR (Israel)

  • TFDA (Chinese Taipei)

Contacts will be available on the RHI and Affiliate Membership pages as they become available.

The 24th Management Committee Meeting of the IMDRF was held from 25-29 September, 2023 in Berlin, Germany. Details of the event can be accessed here.

The 2024 IMDRF Chair and Secretariat is held by the United States of America. Upcoming rotations of Chair and Secretariat responsibilities can be viewed here.

 

The 25th Session of the IMDRF, hosted by the USFDA, will be held in Washington DC, USA from 11-15 March 2024. 

Registrations for the public events have now closed. Further information about the event can be found 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