Participation In The Fast-Expanding Medical Device Market In The People’s Republic Of China: Understanding Medical Device Regulations And Clinical Evaluation Report Requirements

By Izi Bruker, PhD, MPH, Fellow, Clinical, Medical, and Regulatory Affairs, Kymanox Corporation

The People’s Republic of China (PRC) presents a rapidly expanding medical device market, offering immense opportunities for manufacturers and distributors with an expected growth rate of 8.3% between 2021-2026. However, navigating the intricate regulatory landscape can be challenging. To successfully enter this market, it’s crucial to stay abreast of the evolving regulations, particularly those surrounding Clinical Evaluation Reports (CERs).

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