Medtronic, along with Three Domestic Device Makers, Proceeds to Fast-track Review

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CMDE granted innovation and priority review status to four manufacturers in May, by which they can begin the fast-track application process. The complete list is as follows:

Cardiovascular

  • Medtronic: Leadless Pacemaker
  • MicroPort: Cardiac Cryoablation System

Radiology

  • United Imaing: Radiation Therapy Planning System Software

Clinical Chemistry     

  • Xiamen Zhishan: Mycobacterium identification kit

How to Get the Innovation Priority Fast Track Designation

The final version of “Innovation Approval Procedure for Medical Devices” published on November 5, 2018 lists four criteria for manufacturers to apply:

  • Provide Class II / Class III medical device with significant clinical application value,
  • Own valid invention patent and have China Patent & Trade Office coverage,
  • Complete the preliminary study on prototype with traceable data, and
  • Have an authorized in-country legal entity.

If the “Innovation Device designation” 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 CFDA reviewing/approving processes. Meanwhile, a designated NMPA officer would check in and provide guidance throughout the whole expedited process.

Key Takeaways for Overseas Manufacturers

Overseas manufacturers have to bear in mind that:

NMPA gives overseas manufacturers an equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones.

  1. “Conditional Approval” applies for urgently needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweigh the risks, and the manufacturers are committed to do further clinical research
  2. They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent
  3. Having been granted “designation” does not mean “approval”. With ‘front-of-queue’ priority, they still have to go through the normal review process.

This fast-track channels will greatly accelerate the registration process and CMD and help you evaluate the possibilities of your application. For other NMPA fast-track channels, please click HERE.