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
The 28th IMDRF Management Committee Meeting was hosted by MHLW and PMDA in Sapporo, Japan from 15 to 19 September 2025. Presentations and the Outcome Statement from this meeting can be found under Meetings.
The 29th Session will be held in Singapore from 9-13 March 2026. Event details are available here.
The 2026 IMDRF Chair and Secretariat is held by Singapore. Upcoming rotations of the Chair and Secretariat can be viewed here.
Working groups
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
Seeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices
A working group on Clinical evidence for in vitro diagnostic (IVD) medical devices
Develop good review practices for pre-market reviews and evaluations.
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.
Ensure alignment of IMDRF QMS and risk management documents with current international standards
Harmonize the format and content of regulatory submissions.
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.