The Medical Devices Introductory Course 2020

The Organisation for Professionals in Regulatory Affairs

Global Harmonisation

International Medical Device Regulators Forum [www.imdrf.org] • Medical Device Regulatory Agency forum to discuss medical device regulatory harmonization and accelerate international MD regulatory convergence • Originally founded as GHTF in 1992 by EU, US, Japan, Canada and Australian device regulatory authorities (with regulated industry*) • Current membership = Australian TGA, Brazil (ANVISA), Health Canada, EU (Commission), China (NMPA), EU (Commission/MSCA), Japan (PMDA/MHLW), Russia (MoH), Singapore (HCA), US FDA • Affiliates / Observers: AHWP, APEC LSIF, PAHO, WHO • Current / recent work areas: – IVD Classification – MD Cybersecurity Guide [Principles & Practices Final Doc March 2020] – MD Clinical Evaluation – Regulated Product Submission (RPS) (harmonised registration format – previously “STED”) – Personalised MDs [Regulatory Pathways Final Doc March 2020] – Adverse Event Terminology [Final Doc March 2020] – Good Regulatory Review Practices – competence and training [Reg Auth recognition of CABs Final Doc March 2020] • Previous / closed work items – now progressed to operational / implementation stages – National Competent Authority Report (NCAR) (vigilance / corrective action reporting) – Software as a medical device (SaMD) – MDSAP (single audit programme) – Roadmap for UDI – Recognised Standards / Improving quality of international standards for regulatory use – MD Patient Registries

* Industry representation no longer included with IMDRF