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12:0012:30 19. Nov 2019
12:0012:30 19. Nov 2019 iCal myOrganizer
MEDICA TECH FORUM

MTF: China – Market access and regulatory update

Session Internationaler Marktzugang und regulatorische Anforderungen

Abstract:

China continuingly relies on high-end and high-cost medical products from abroad. The lecture deals with recent regulatory updates surrounding the registration of medical devices in China. Firstly, the responsible authority, the NMPA (National Medical Products Administration) and China’s institutional restructuring are introduced. Then, the new responsibilities of NMPA Legal Agents in adverse events are explained. Here, the careful choice of Legal Agent is of high importance. Other recent regulations are covered, including the necessity of UDI (Unique Device Identification) barcodes for medical devices, new ways of product risk classification and overseas factory inspections. The presentation also examines topics causing issues for MedTech manufacturers, for instance, type tests and clinical trials in China and the life time of medical devices.