APEC Regulatory Harmonization Steering Committee (RHSC)
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The International Medical Device Regulators Forum (IMDRF) is continuing the work of the Global Harmonization Task Force (GHTF).
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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.
Working group
Improve the effectiveness and efficiency of the pre-market review process by promoting increased global harmonization.
Working group
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.
Working group
Develop good review practices for pre-market reviews and evaluations.
Working group
Harmonize the format and content of regulatory submissions.