Eight reform measures of medical device evaluation

in recent years, in order to guide the applicant's research and development and standardize the internal evaluation scale, the instrument Audit Center has continuously strengthened the compilation of the guiding principles. We have organized and completed the preparation of 200 guiding principles for technical review of medical devices required by the 13th five year plan, including 52 in 2017 and 61 in 2018. At the same time, the center integrates the guiding principles of technical review into the management of the quality management system for review, and takes this as a means to unify the review standards and review requirements at all levels, and promote the unified work of domestic technical review.

Constructing the whole process consultation and exchange mechanism

In recent years, on the basis of the shortage of evaluation resources, the equipment audit center has taken the initiative to increase pressure, and insisted on broadening the communication channels with the applicants. The center has formulated and issued the "management measures for communication and communication of medical device review (Trial)", which unblocks the communication and communication channels for innovative medical devices and priority approval of medical devices. Special personnel are responsible for early intervention, and communication and exchange meetings are organized and held to timely communicate and solve the problems of applicants in the process of product development, application and evaluation. At present, the center has standardized and formed five kinds of consultation and communication systems, covering the whole process of the review of products before registration and application, before the application for clinical trials to be approved, in the process of acceptance, in the process of evaluation, as well as in the evaluation of innovative and priority products. Through the establishment of an efficient and smooth communication platform, the quality of product registration and declaration can be effectively improved. While serving the enterprise, the evaluation efficiency has been further improved.