APEC Regulatory Harmonization Steering Committee (RHSC)
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Results
Archive
GHTF Study Group 1 - Pre-market Evaluation documents
Archive
GHTF Study Group 2 - Post-market Surveillance/Vigilance documents
Archive
GHTF Study Group 5 - Clinical Safety/Performance documents
Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa, Closed 10 September 2019.
Consultation
IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa - Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Closed Wednesday, 31 May 2017.
Consultation
IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Closed Friday, 12 October 2018.
Consultation
IMDRF Principles and Practices for Medical Device Cybersecurity, Medical Device Cybersecurity Guide Working Group, Coordinator Suzanne Schwartz, Closed 2 December 2019.