APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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.
Consultation
Machine Learning-enabled Medical Devices - Key Terms and Definitions, Artificial Intelligence Medical Devices (AIMD), Coordinator Young-kyu Kang, Closed 29 November 2021
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
Consultation
Principles and Practices for Software Bill of Materials (SBOM) for Medical Device Cybersecurity - Good Regulatory Review Practices, Coordinator Dr Aftin Ross
Consultation
Personalized Medical Devices Regulatory Pathways - Personalized Medical Devices
Consultation
Personalized Medical Devices Production Verification and Validation, Personalized Medical Devices
Consultation
Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)