The Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) have created significant impact in the medical device industry in China. The changes affect products at each stage of their life cycle and impact both local and multinational MedTech players in China.
A white paper co-authored by McKinsey & Company and Ropes & Gray life sciences partner Katherine Wang (Shanghai) builds on the highly relevant discussions from the annual China regulatory affairs (RA) roundtable (jointly hosted by Ropes & Gray and McKinsey & Company) and provides an update on the major regulatory changes and their impact on the industry. The paper discusses implications for the role and standing of the RA function in medical device companies, and how the RA function needs to evolve in anticipation of future trends.
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