Innovated Medical Devices CFDA Priority Approval - Regulatory News - Medical Devices

February 10^th 2014, CFDA issued ‘Innovated medical devices special approval procedure (trial version)’

What kind of products can apply for the CFDA priority approval?
CFDA will give registration application priority approval for the domestic class III medical devices and imported class II and class III medical devices that conform to the following conditions:

I) Medical devices belong to the CFDA priority approval

Medical devices can diagnose or treat orphan diseases and have significant clinical benefit
Medical devices can diagnose or treat malignant tumor and have significant clinical benefit
Medical devices can diagnose or treat unique and multiple diseases and do not have any significant diagnosis or treatment.
Medical devices are exclusively used for the child and have significant clinical benefit
Medical devices under clinical urgent need and do not have any similar CFDA registered products

II) Medical devices included in the important national scientific projects list or national emphasized research and developing plan can apply for the CFDA priority approval.

III) Other medical devices can apply for the priority approval
CFDA will also give priority registration application approval for the innovated medical devices that conform to the following conditions:

Applicants have the product core technical innovation patent through the technical innovated activities. The second condition is the applicants have the patent or can use the patent through the transfer. The third condition is that the product core technical innovation patent published by the administrative department for patent under the state council.
Products working principle/mechanism is domestic initiative. Compare to the congeneric products, these products have fundamental change on the performance or safety. These products are the advanced level in the world and have significant clinical application value.
Applicants already finished the pre-research and the products basically finalized. The research process real and controlled. And the research data complete and traceability.

Which department should the manufactures apply for priority approval?
Center for Medical Device Evaluation (CMDE) established the innovated medical device investigate office to give permission to the innovated medical device priority approval. And during the approval process, the officers will also define the medical device management catalog.

CFDA priority approved imported medical devices

Products name	Applicants	Publish date
The renal artery sympathetic multipolar radiofrequency catheter system(CN: 腎動脈交感神經多極射頻消融導管系統)	Medtronic, Inc.	07/18/2017
Collagen carrier cartilage regeneration(CN:膠原蛋白軟骨再生載體)	Ubiosis Co.Ltd	03/07/2017

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