[Special Session of Pharmaceutical Supervision] Wang Zhexiong: Emphasis on Medical Device Registration Management in 2018

  • 2018-04-03

On March 31st, 2018, Wang Zhexiong, former Director of the Department of Medical Device Registration of China Food and Drug Administration, attended the Second Meeting of Sixth Member Representative Conference of China Association for Medical Devices Industry and 2017 Annual Policy Conference and delivered a keynote speech on “New Management Progress on Medical Device Registration”.

Mr. Wang first briefed the participants on China’s domestic registration of Class III and imported medical device products in 2017. In 2017, 3,300 domestic Class III medical device registrations were approved, an increase of 13.7% compared to 2016; 5,623 imported medical device registrations were approved, down by 2.3% compared to 2016; 8923 medical device registrations, renewals and licensing changes were approved, an increase of 3.1% from 2016; 5475 medical device registrations were approved, accounting for 61.4% of all medical device registrations; 3178 vitro diagnostic reagent registrations were approved, accounting for 35.6% of all medical device registrations. In general, the quantity of registrations accepted or examined and approved doesn’t change much, indicating that with the continuous improvement of China’s relevant laws and regulations, enterprises tend to rationally submit their applications.

Mr. Wang went on and briefed the attendees on the 2017 medical device registration management concerning the following aspects: gradually perfected regulatory system for medical device registration management, orderly proceeded reform of the examination and approval system, continuously consolidated medical device registration management system, continuously strengthened verification of the registration procedures and supervision and management of clinical trials, comprehensively enhanced capacity of reviewing, approving and approving provincial medical devices, comprehensively deepened prospective policy research on medical devices, increasingly intensified international exchanges and cooperation, and further reinforced informatization and information disclosure.

When talking about the key work plan in 2018, Mr. Wang said that the department will continue to: implement the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices issued by the Central Office and the General Office of the State Council; focus on implementing the medical device holder system and pinpoint legal responsibilities of the holder for the whole process and entire life cycle of the design and development of medical devices, clinical trials; carry out supporting regulations such as the Administrative Measures for Medical Device Registration and the Administration of IVD Reagent Registration in conjunction with the officially released the Regulations amendments, so as to ensure the sound progress of the reform work in terms of rules and regulations; formulate the Management Regulations for the Revision of Guiding Principles for Medical Device Technology Review, revise the 40 guidelines for technical review of medical device registration, and further improve the regulatory system for medical device registration management through the above specific measures.

The department will continue to strengthen the review of innovative products, revise the Special Procedures for Examination & Approval of Innovative Medical Devices, further revise and perfect Standard Review Procedures for Application of Special Examination & Approval of Innovative Medical Devices, and Standard Review Procedures for Application of Prior Examination & Approval of Medical Devices (Interim)”, and continue to push forward the review of innovation applications and prioritized applications, and promote researches and innovations to meet urgent clinical needs. At the same time, the department will continue to revise the Guiding Principles for Clinical Evaluation of Medical Devices, study and draft the Administrative Measures for the Development of Medical Device Expansive Clinical Trials, and refine the inspection key points and principles for the clinical trials of medical devices to improve clinical evaluation requirements and strengthen on-site inspections.