APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Page
Consultations of the International Medical Device Regulators Forum (IMDRF) or it’s working groups.
Page
Medical device safety information published by the National Competent Authority Report (NCAR) Exchange Members.
Page
The International Medical Device Regulators Forum (IMDRF) requires close collaboration with regulators and industry stakeholders.
Page
The International Medical Device Regulators Forum (IMDRF) is continuing the work of the Global Harmonization Task Force (GHTF).
Page
Contact details for the International Medical Device Regulators Forum (IMDRF) Chair and Secretariat to get in touch.
Working group
The working group’s mandate was to deliver on Key Terms and Definitions for Machine Learning-enabled Medical Devices.
Working group
Review and update the GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.
Working group
Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.