The "2017 Medical Device Registration Work Report" (hereinafter referred to as the "Report") is freshly "baked". The "Report" comprehensively shows the progress of the medical device registration acceptance and evaluation, the reform of the review and approving system for medical device audits in the past year, and focuses on the approval of innovative medical devices.

According to the data, in 2017, the national food and drug regulatory agency accepted 6,834 applications for registration of medical device registrations, continuation of registrations, and changes in licensing matters; completed 8,579 technical reviews of registration applications; approved medical device registration, continued registration, and licensing changes to register 8923 Projects; intervention in artificial bio-heart valve and other 12 innovative products through the special approval channel to accelerate the market, meet the urgent needs of the clinical, bring happiness for people's lives, and scientifically guide the development of industrial innovation.

Registered domestic products increased by 13.7%

The reporter was informed that in 2017, the national food and drug regulators conscientiously implemented the "Regulations on the Supervision and Management of Medical Devices" and the "Opinions on Reforming the Approval System for Drugs and Medical Devices" of the State Council, and the "In-depth review and appraisal and approval system of the China Office and the State Council". The "Opinions on Reforming and Encouraging the Innovation of Drugs and Medical Devices" require the continuous deepening of the reform of the review, approval and approval system for medical devices, further strengthening the supervision and management of registration of medical devices throughout the country, and strengthening the inspection of registered sites and the supervision and examination of clinical trials to continuously improve medical devices. Registration review review batch quality and efficiency.

The "Report" shows that in the past year, the national food and drug regulatory agency (the same below) has accepted 6,834 applications for registration of medical device registrations, continuation of registrations, and licensing changes, a decrease of 23.4% year-on-year. Among them, 2457 applications for registration of the third type of medical devices in China and 4,377 applications for registration of imported medical devices were accepted. A total of 8,579 technical reviews of medical device registration applications were completed, a decrease of 8.1% year-on-year. Of these, 1,507 were registered for the first time, 5,218 were registered, and 1,854 were changed. A total of 8,923 new medical device registrations, continuation of registrations, and licensing changes were registered, an increase of 3.1% year-on-year. Among them, 1,379 medical devices were approved for the first time. Approval of 3,300 registrations of Class III medical devices in China, an increase of 13.7% year-on-year; 5,562 approvals for registration of imported medical devices, a decrease of 2.3% year-on-year. 223 medical device registration applications will not be registered, the company will withdraw 331 of its own.

 Amplitude integration

Registered medical polymer products soared by 56.5%

The "Report" shows that the amplitude of the integration of the territory of the third category of medical devices approved for registration in 2017, in addition to in vitro diagnostic reagents, involved a total of 25 sub-categories of products in the "Medical Device Catalog". The top five in terms of registrations are: medical polymer materials and products, implant materials and artificial organs, injection and puncture devices, medical optical instruments, instruments and endoscopic equipment, operating rooms, emergency rooms, and treatment room equipment. appliance. Among them, the number of registered medical polymer materials and products increased significantly by 56.5% year-on-year, jumping from the second to the first; and the number of implants and artificial organs registered dropped by 10.5%, ranking second; medical optical instruments and instruments And the number of registered products for endoscopic equipment and injection and puncture devices was basically the same; the number of equipments and apparatus products for operating rooms, emergency rooms, and treatment rooms increased by 24.3%, ranking fifth. In addition to in-vitro diagnostic reagents, imported medical devices approved for registration in 2017 are related to products in 40 sub-categories of the Catalogue of Medical Devices. The top five in terms of registrations are: implanted materials and artificial organs, medical optical instruments, instruments and endoscopic equipment, dental materials, medical polymer materials and products, and medical electronic equipment. Compared with 2016, implanted materials and artificial organs remained at the top of the list, but they were down 5.1% year-on-year, medical polymer materials and products, and medical electronic equipment declined, while stomatologic material products increased. Larger, replacing the operating room, emergency room, clinic equipment and appliances into the top five.

The "Report" mentioned that from the perspective of the registration of the third category of medical devices within the territory, the related registered products manufacturing enterprises are mainly concentrated in the more economically developed coastal provinces. Beijing, Jiangsu, Guangdong, Shanghai, and Zhejiang are the top five provinces in terms of the number of registrations for the third type of medical devices in China, accounting for 66.7% of the number of registrations for the third type of medical devices in China in 2017.