APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)
Consultation
Guiding Principles to Support Medical Device Health Equity (N79)
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
Consultation
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.