APEC Regulatory Harmonization Steering Committee (RHSC)
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Results
Consultation
Medical Device Software: Considerations for Device and Risk Characterization, Software as a Medical Device Closes 2 May 2024
Consultation
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Artificial Intelligence/Machine Learning-enabled Working Group is provided below for public comment.
Consultation
Considerations for the Selection of IMDRF Adverse Event Terminology
Working group
A working group on Clinical evidence for in vitro diagnostic (IVD) medical devices
Consultation
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.
Page
Search utility for the Annexes collating Adverse Event related terminology
Working group
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
Event
IMDRF 28th Session, September 15-19 2025, Sapporo, Japan