How to expedite your registration?Is there any tips? Maybe the innovation path suits you!
The National Medical Products Administration (NMPA) thinks highly of the innovation of medical devices. Until now, a total of 109 innovative medical devices from 91 companies have been approved by NMPA, including four foreign ones. Please see the table below for the four enterprises.
No. | Product Name | Manufacturer | Approval Date | Country |
1 | Micra Transcatheter Leadless Pacemaker system | Medtronic Inc. | June 11 2019 | USA |
2 | Tumor Treating Fields | NovoCure Ltd. | May 11 2020 | Israel |
3 | Transcatheter Aortic Valve System | Edwards Lifesciences LLC | June 5 2020 | USA |
4 | MitraClip System | Abbott Vascular | June 15 2020 | USA |
In 2018, NMPA issued Procedures for the Special Review of Innovative Medical Devices. This procedure sets up a special approval channel for medical devices that have Chinese invention patents, are technologically domestically pioneering, internationally advanced, and have significant clinical application value.
Contact us for more information about detailed requirements for the special approval channel for innovative medical devices.