APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
Personalized Medical Devices Regulatory Pathways - Personalized Medical Devices
Consultation
Personalized Medical Devices Production Verification and Validation, Personalized Medical Devices
Consultation
Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)
Consultation
In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)
Page
The IMDRF Chair and Secretariat rotate on a yearly basis across Management Committee member jurisdictions.
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Working group
Seeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices
Consultation
Guiding Principles to Support Medical Device Health Equity (N79)
Working group
Ensure alignment of IMDRF QMS and risk management documents with current international standards