Up to 19 Products Approved in 2019, 73 Innovative Medical Device Products Approved for the Market to Date

  • 2020-01-02

In recent years, National Medical Products Administration (NMPA) has been implementing Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices (GF [2015] No. 44) and Opinions of the General Office of CPC Central Committee and General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices (TZ[2017] No. 42) to further advance the reform of the review and approval system for medical devices and accelerate the innovation of medical devices. For innovative medical devices that wait to be reviewed and approved, NMPA will carry out scientific review and approval through early intervention, arrangement of designated personnel, multiple communication, expert consultation, etc. and prioritize the review and approval of such products on the premise of "not lowering the standards and reducing the procedures". Statistics show that the time for the review and approval of innovative medical devices is averagely 83 days shorter than that for the review and approval of other three general types of first registered products, which means that the time it takes for an innovative product to go on the market is further shortened.

Since the release of Special Approval Procedures for Innovative Medical Devices, as of December 31, 2019, totally 236 products have entered the special review channel for innovative medical devices, and 73 innovative products have received the registration certificate.

From the locations of the 73 approved products, we can draw the conclusion that traditional industrial provinces have the largest number of innovative medical devices. Respectively, Beijing, Shanghai, Guangdong and Jiangsu have 21, 15, 11 and 11 innovative medical devices. In terms of the types of approved products, there are 33 implanted medical devices, 14 diagnostic equipment, and 14 in vitro diagnostic reagents.

 

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