APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
Software as a Medical Device (SaMD): Clinical Evaluation, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 13 December 2016.
Consultation
Software as a Medical Device (SaMD): online survey now open, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Monday, 3 August 2015.
Consultation
Software as a Medical Device (SaMD): Application of Quality Management System, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 01 June 2015.
Consultation
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.
Consultation
Standalone Software: Key Definitions, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
Consultation
Optimizing Standards for Regulatory Use, IMDRF recognized standards Working Group, Coordinator Matthias Neumann, Closing date 24 May 2018.
Consultation
Unique Device Identification system (UDI System), Unique Device Identification system (UDI System) Working Group, Coordinator Salvatore Scalzo, Closed 12 October 2018.
Consultation
UDI System for Medical Devices, Unique Device Identification (UDI) Application Guide Working Group, Coordinator Salvatore Scalzo - European Commission, Closed Saturday, 31 August 2013.
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.
Page
International Medical Device Regulators Forum (IMDRF) closed working groups that have completed work tasks requested by the IMDRF Management Committee.