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.

Electronic application materials

The center is working hard to study and formulate the content, format and coding requirements of the electronic submission information system for medical device registration in China, and strive to establish a unified online application platform for medical device acceptance, review and approval, so as to realize the electronic submission and review and approval of medical device registration application.

At the beginning of this year, the center organized the drafting of technical guidelines for electronic submission of medical device registration application (Trial) (Draft for Soliciting Opinions), and solicited opinions in the name of drug administration on May 23. The system is fast and can be put into trial operation next year.

Electronic consultation materials for professionals

Since November 2017, the center has changed the existing data review mode of professional consultation meetings, sending the data to professionals for review before, and adjusting it to the electronic version of the application materials for on-site review by professionals. The purpose of this change is to avoid the risk of product R & D information leakage caused by sending the application materials in advance. At the same time, the center strengthens the internal management, and special personnel are responsible for receiving, copying, deleting and returning the electronic version of registration data, so as to improve the confidentiality of the application materials.

Introduction of professional video review mode

From November 2017 to March 2018, the center signed cooperation agreements with food and drug regulatory authorities of Zhejiang, Guangdong, Jiangsu and Shanghai, established provincial innovation service stations, and built a scientific, standardized and efficient management system for medical device review and approval. Through various forms of cooperation, we can improve the ability of provincial evaluation institutions, unify the evaluation and approval criteria, strengthen the guidance of innovative medical device R & D registration, and exchange and cultivate talents.

Relying on the video conference room established by the provincial innovation service station, the center tried to conduct professional video review on the application for special approval of innovative medical devices applied by the applicant in May 2018.

By means of video conference, the exchange and interaction between professionals and applicants are increased, which is conducive to professionals' in-depth understanding of products and improving the scientificity of review opinions. At the same time, it also makes enterprises more clear about the deficiencies in the materials, reduces the burden of enterprises' travel to Beijing, and provides help for enterprises to invest more resources in product R & D process. In addition, the relevant comrades of the Provincial Bureau participated in the review meeting, which also provided guidance for the preliminary examination of the application materials for special approval of innovative medical devices.