The meeting summarized the national medical device review work over the past year, studied and analyzed the situation faced by the reform of the medical device review and approval system, explored measures to deepen the reform of the review system and mechanism, and put forward requirements for the next stage of medical device review.

Jiao Hongpointed out that

Since the State Council issued the Opinions on Reforming the Review and Approval System for Drugs and Medical Devices in August last year,The State Food and Drug Administration has thoroughly implemented the reform opinions, issued the Comprehensive Reform Plan of the Medical Device Technical Review Center, optimized the review mode and process, accelerated the review of innovative medical devices, strengthened the construction of review capacity, and continuously improved the scientific level of review.Under the circumstances of few personnel and heavy tasks, local review institutions have taken effective measures to earnestly perform their duties. The national and provincial (regional, municipal) medical device review and approval system has gradually improved, and new steps have been taken in various tasks.

Jiao HongEmphasis

The technical review of medical devices is a link to ensure access to the source of public equipment.Social attention is high and has a great impact on the industry. At the same time, new technologies and new products such as medical robots, mobile medical equipment, high-throughput genetic diagnosis, and 3D printing customization continue to emerge, which also puts forward higher requirements for review capabilities. In the face of the new situation and new tasks, we should take advantage of the situation, innovate boldly, constantly improve the medical device review system, and enhance the ability and level of medical device review.

Jiao HongRequirements

A series of major decisions made by the State Council on the reform of the examination and approval system for drugs and medical devices show the strong determination of the CPC Central Committee and the State Council to ensure the public use of medical equipment.The food and drug regulatory system must thoroughly study and understand the requirements of the Party Central Committee and the State Council on ensuring food and drugs, and understand the review of medical devices from the height of enhancing the "four consciousnesses", and have a role, contribution, and responsibility in ensuring the use of public equipment. It is necessary to further implement the reform opinions of the State Council, further promote the reform of the review mechanism, and continuously improve the effectiveness of the review. It is necessary to resolutely implement the requirements of the central government on reforming the food and drug regulatory system, allocate resources in accordance with public functional positioning, and further establish and improve review institutions. It is necessary to establish an institutionalized, standardized, professional and systematic training system to comprehensively improve the ability and level of the review team. We should continue to promote the construction of a clean government and build a pragmatic and honest evaluation team for the people.

At the meeting, Kong Fanpu, director of the Medical Device Technology Review Center of the General Administration, made a work report, and Wang Yingjun, academician of the Chinese Academy of Engineering and president of South China University of Technology, made a work report."Biomedical Materials Research and Development"Special reports.The relevant person in charge of the Medical Device Registration Management Department of the General Administration introducedMedical Device Registration Management and Review and Approval System Reform. Representatives of the General Administration and relevant directly affiliated units, heads of provincial medical device technical review institutions (corresponding units) and relevant personnel attended the meeting.