NMPA granted Innovation Approval designation to eight medical devices on November 2, 2020.
|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.