APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Working group
Initiatives undertaken on behalf of the IMDRF Management Committee
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.
Page
International Medical Device Regulators Forum (IMDRF) working groups may be established by the Management Committee (MC) to progress harmonization guidances.
Consultation
Proposed update to document on Post-Market Clinical Follow-Up Studies, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu, Closed 11 December 2020.
Consultation
Proposed update to Clinical Evaluation documents, Medical Device Clinical Evaluation Working Group, Coordinator Dr Yinghui Liu - Center for Medical Device Evaluation (CMDE), Closed Wednesday, 5 June 2019.
Consultation
IMDRF Terminologies for Categorized Adverse Event Reporting: terms, terminology and codes, Adverse Event Terminology Working Group, Coordinator Hiroshi Ishikawa - Pharmaceuticals and Medical Devices Agency (PMDA), Closed Friday, 2 December 2016.
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 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.
Working group
Review the GHTF NCAR Exchange Program and to advise on opportunities for improvement
Consultation
Considerations for the Selection of IMDRF Adverse Event Terminology