Seven Cardio Devices Proceed to Innovation Approval

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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.

If you have any further questions about anything related to this topic, please contact us at info@chinameddevice.com

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