The Medical Devices Introductory Course 2020

Global Harmonisation - GMDN

• The GMDN is recommended by the International Medical Device Regulators Forum (IMDRF) and is now used by over 70 national medical device regulators to support their activity. The GMDN is managed by the GMDN Agency, a registered charity, which has a Board of Trustees, which represent regulators and industry.

Global Harmonisation

Medical Device Single Audit Programme (MDSAP)

• Programme ongoing to enable audit by single “Auditing Organisation” (AO) to cover / replace current requirements for multiple audit / inspections • Current participating jurisdictions: – Australia – Brazil – Canada – Japan – US • “Observers”: EU and WHO • 6+ AO’s currently authorised to perform MDSAP audits and multiple audits completed • Health Canada require MDSAP audits for all licensed medical devices since 1 January 2019 (replacing previous “CAMDCAS” audits) • Developed from “STED” format approach to create a uniform regulatory submission format (similar to CTD approach for medicinal products) • STED previously developed by GHTF (prior to IMDRF) and similar to MDR Annex II Technical Documentation content • RPS more extensive than STED and combines multiple regulatory agency format / content elements (including FDA) • Pilot ongoing? Status unclear – one licensed suture product in Canada, undergoing review in China and Brazil (?) Regulated Product Submission (RPS)