The NMPA granted four fast-track statuses in July 2021, among them are two cardio devices:
- Corindus: Coronary Artery Surgery Control System
- Shenyang Pengyue: Cardiac Cryoablation System
- Suzhou Hongyuan: Chromosome Abnormality Detection Kit for Urothelial Carcinoma
Priority review status for Cardio Devices fast track
- Beijing Fanshengzi Genetech: Human PDGFRA Gene D842V Mutation Detection Kit
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.