Life sciences partner Katherine Wang (Shanghai) chaired a medical device regulatory affairs roundtable co-organized with McKinsey & Company in Beijing on May 18. The roundtable brought together senior regulatory affairs (RA) leaders from multinational medical device companies, including Medtronic, Baxter, Becton Dickinson, J&J Medical, Smiths Medical, Stryker and Abbott Vascular.
Katherine led discussions on the key China regulatory updates affecting MedTech operations in China and how the RA function can be better prepared for these changes. Attendees had in-depth discussions on a variety of topics. The group discussed adapting PRC mandatory device standards with international practices, optimizing clinical evaluation and admission of foreign clinical data, and coping with future intensified post-market enforcement. RA leaders also shared their experiences in exploring the device MAH pilot program and lobbying the regulator to re-classify certain devices.
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