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Three Cardio Device Manufacturers Proceed to Innovation Pathway

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The NMPA granted four innovation review statuses on June 22, 2021, three innovation cardio devices which are cardiovascular-related and one for intraperitoneal surgery:

  • Chengdu Sailanuo Medical: Endovascular Aortic Stenosis System
  • Shenzhen Hexin Medical: Implantable Left Ventricular Assist System
  • Shanghai Niumag: Endovascular Mitral Valve Repair System
  • Chengdu Boensi Robotics: Intraperitoneal Surgery System

How to Qualify the Fast-track Channel

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.

For Priority Review, applicants need to meet one of the following scenarios:

  • Treat rare diseases with significant clinical application value,
  • Diagnose or treat malignant tumors with significant clinical application value,
  • Diagnose or treat geriatric diseases, with no effective diagnosis or treatment
  • Be intended for pediatric diseases with significant clinical application value,
  • Be intended for unmet medical needs, which currently have no effective diagnosis or treatment, or
  • Be listed in National Science and Technology Major Projects or National Key R & D Plans

If the “fast-track channel” 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