APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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Closed consultations of the International Medical Device Regulators Forum (IMDRF) or its working groups.
Consultation
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Wednesday, 18 April 2018.
Consultation
Principles of Labeling for Medical Devices and IVD Medical Devices, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres - US Food and Drug Administration (FDA), Closed Wednesday, 12 September 2018.
Consultation
Machine Learning-enabled Medical Devices - Key Terms and Definitions, Artificial Intelligence Medical Devices (AIMD), Coordinator Young-kyu Kang, Closed 29 November 2021
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The IMDRF Industry Group assists the IMDRF Management Committee (MC) in international harmonization efforts
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International Medical Device Regulators Forum (IMDRF) closed working groups that have completed work tasks requested by the IMDRF Management Committee.
Working group
The working group’s mandate was to deliver on Key Terms and Definitions for Machine Learning-enabled Medical Devices.
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List of committee members of the International Medical Device Regulators Forum (IMDRF) Management Committee (MC).