Advancing medical device regulatory reforms for innovation, translation and industry development in China.

Abstract

The blossoming Chinese medical device market calls for a science-based regulatory system in China. Consistent efforts have been made to advance the medical device regulatory reforms for innovation, translation and industry development. In this article, we report both the latest regulatory requirements which aim to ensure safety and efficacy for patients while encouraging innovation of the medical device industry, and the key programs on medical devices covered in the Regulatory Science Action Plan (RSAP) of the National Medical Products Administration of China (NMPA). The main features of the revised regulations are first elucidated before the opportunities for translational research are interpreted, including those for additive manufacturing and customized devices, drug–device combination products, artificial intelligence-powered software and surgical robots, and nanomaterials for medical devices. Finally, a regulatory perspective is provided to researchers who expect to translate their technologies in the Chinese medical device market. Important issues including early attention to critical market and clinical needs, understanding the true principle and spirit underlying the changing regulations and standards, and protecting intellectual property rights with comprehensive measures, are discussed. These developments warrant further investigations into the distinct role of regulatory science in shaping medical devices research and development.