NMPA granted Innovation Approval designation to eight medical devices on November 2, 2020.
Product Name | Manufacturer |
Pulsed Field Ablation System | Medtronic, Inc. |
Bronchus RF Ablation Systems | Suzhou Xinmai Medical Equipment Co., Ltd. |
Catheterized Mitral Valve Replacement System | NewMed Medical Co., Ltd. |
Tumor Treating Field Equipment | Hunan Antai Kangcheng Biological Technology Co. LTD |
Orthopedic Surgery Navigation and Positioning System | Tinavi Medical Technologies Co., Ltd. |
Multimodal Tumor Radiofrequency Therapy System | Shanghai Meijie Medical Technology Co., LTD |
Self-expurgated Particle Biliary Stent | Nanjing Rongsheng Medical Technology Co., LTD |
Three-branch Aortic Stent and Delivery System | Beijing Tianzhu Changyun Medical Technology Co., Ltd. |
The final version of “Innovation Approval Procedure for Medical Devices” published on November 5, 2018 lists four criteria for manufacturers to apply:
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.
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.
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.