APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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.
Consultation
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres, Closed date 19 April 2021.
Consultation
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Closed 26 May 2020.
Consultation
Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies, Good Regulatory Review Practices Working Group, Coordinator Melissa Torres, Closed 9 May 2020.
Consultation
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, Good Regulatory Review Practices Working Group, Closed 3 October 2019.
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
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.