NMPA granted ten special statuses in August 2021, among them are seven innovation cardio devices:
- Boston Scientific Corporation: Vascular Plaque Atherectomy System
- TriReme Medical: Paclitaxel Drug-Coated Peripheral Balloon Catheter
- Shandong Weiji: Umimus Coated Coronary Artery Balloon Dilatation Catheter
- Hanzhou Dejin: Transapical Mitral Valve Repair System
- Shanghai Xinwei: Intracranial Artery Drug-coated Balloon Catheter
- Jinshi Bio: Transcatheter Aortic Valve System
- Shanghai Shenqi: Transcatheter Mitral Valve Clamp and Steerable Guiding Catheter
- Guangzhou Ruiqina: Macular Compression Band
- Beijing Pingchi: Deep Brain Stimulation System
- Jiangsu Jingce: Non-invasive Blood Glucose System
How to Qualify the Innovation Approval?
Three fast-track channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.
The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices manufacturers to apply:
- Provide significant clinical application value,
- Own valid invention patent and have China Patent & Trade Office coverage,
- Complete the preliminary study on a prototype with traceable data, and
- Have an authorized in-country legal entity.
If the “innovation status” is granted (which does not mean “approval”), the device will be allocated ‘front-of-queue’ priority throughout the registration process. The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, a specially assigned NMPA officer would check in and provide guidance throughout the whole expedited process.
The fast-track channels will greatly accelerate the registration process and CMD and help you evaluate the possibilities of your application. For our comprehensive review of the fast-track channels, please click HERE.