Medical Device Regulation

This chapter examines the robust growth in medical device regulation in China, which has accompanied the growth of the industry and the increasing level of medical technology approved for use in health care in China. It discusses the general procedures and requirements for pre-market approval and risk-based regulation over the life cycle of devices, into the post-market environment. It also examines more specific methods for regulating certain types of devices, including digital health products, through specific standards and, more recently, technical guidelines.