RESUMEN
The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents. After a brief introduction of Master Files systems established by foreign regulatory agencies, this article focuses on the research of establishing a medical device Master Files registration system in China. The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices, and satisfy the needs of the development of medical device industry and regulatory system. At the same time, the probability of additional risk caused by the implementation of the system is low. Therefore, it is expected that the benefits of the system to promote public health outweigh the potential risks, which demonstrates that establishment of the system has important application values.