The Medical Devices Introductory Course 2020

Global Harmonisation

Asian Harmonization Working Party [www.ahwp.info] • 31 member economies across Asia, Middle East, Africa and LatAm • Share IMDRF goals for medical device regulatory harmonization and acceleration of international MD regulatory convergence, especially with respect to: – Regulated Product Submission (originally promoted “STED” submissions across member jurisdictions – MDSAP – AE terminology • Current / Recent Working Groups cover: – Software as a medical device – Quality Management Systems / Standards – IVD – Clinical Evidence – UDI

Global Harmonisation

Global Medical Device Nomenclature (GMDN) [www.gmdnagency.org] • International terminology for medical devices • Compiled by healthcare authority and industry experts • Up to 20,000 terms and more than 10,000 synonyms entered • Currently 20 categories (14 active) with hierarchical sub- categories • Utilised by healthcare authorities for adverse event reporting and for reimbursement coverage • Some health authorities use as a pre-requisite and/or component of device registration process – e.g.: Australian TGA; Japan PMDA use “ JMDN ” (localised version) • Copyrighted and currently requires payment of licence for usage • Prescribed element of current UDI proposals