APEC Regulatory Harmonization Steering Committee (RHSC)
Automatic language translation
Our website uses an automatic service to translate our content into different languages. These translations should be used as a guide only.
Results
Working group
Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking.
Consultation
Machine Learning-enabled Medical Devices - Key Terms and Definitions, Artificial Intelligence Medical Devices (AIMD), Coordinator Young-kyu Kang, Closed 29 November 2021
Working group
Initiatives undertaken on behalf of the IMDRF Management Committee
Page
The Global Harmonization Task force (GHTF) final documents are still current. As the work of IMDRF progresses, these documents will be reviewed and published as IMDRF documents.
Working group
A working group for Clinical Evidence for IVD Medical Devices
Consultation
Principles and Practices for the Cybersecurity of Legacy Medical Devices, Medical Device Cybersecurity Guide, Coordinator Dr Aftin Ross, Closes 3 July 2022
Consultation
Marketing Review Report Work Instruction, Good Regulatory Review Practices, Coordinator Ken Cavanaugh, Closes 8 July 2022
Working group
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.
Consultation
Principles and Practices for Software Bill of Materials (SBOM) for Medical Device Cybersecurity - Good Regulatory Review Practices, Coordinator Dr Aftin Ross