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).

The registration process for the National Medical Products Administration (NMPA) — the primary regulator — involves classifying the device and preparing a registration dossier, including a Clinical Evaluation Report (CER). The CER process draws from US and EU requirements, emphasizing the use of predicate device comparison to establish safety and performance. Manufacturers and distributors must adapt CER content to meet PRC requirements.

Given the complexities of the PRC regulatory landscape, partnering with experienced regulatory consultants can prove invaluable. They can guide you through the intricacies of the NMPA's requirements and ensure your CER is compliant, maximizing your chances of a successful market entry. Review the evolving regulations and learn how collaborating with experts can help to position your company to capitalize on this dynamic market.