54 innovative medical devices have been approved, including 13 in vitro diagnostic reagents and 9 diagnostic devices.

  • 2019-02-18
Since the release of Special Review and Approval Procedure for Innovative Medical Devices, there have been 197 products that entered the special review channel for innovative medical devices, and 54 products approved for registration as of December 31, 2018, encompassing neurosurgical navigation and positioning systems, positron emission tomography and magnetic resonance imaging system, etc.

In terms of the origin of approved products, those provinces and municipalities with large scale industry account for a big part, 18 from Beijing, 10 from Shanghai, 10 from Guangdong, and 8 from Jiangsu.
In terms of the types of approved products, 22 are implanted medical devices, 9 are diagnostic devices, and 13 are in vitro diagnostic reagents.

For products entering the review and approval channel for innovative medical devices, NMPA implements scientific review and approval through early intervention, designated responsibility, multiple communication, expert consultation, etc., under the premise that standards are not lowered, procedures are not reduced, giving priority to innovative medical devices. According to statistics, the average review and approval time for innovative medical devices is reduced by 83 days compared with the other three types of initial registration products, and the time from R&D to marketing is further shortened.
See the following chart for the 54 products approved for marketing since the release of Special Review and Approval Procedure for Innovative Medical Devices.