China’s Medical Device Clinical Evaluation Pathways


This short video discusses the possible clinical evaluation pathways for the China NMPA medical device registration. Chinese regulations for medical devices (including IVD products) follow the US FDA's classification system of Class I, II, and III. When preparing the CER based on predicates, for instance, you must select the most appropriate equivalent device or similar devices that are already approved in China and perform equivalency analysis, literature research, clinical data review, etc.