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The auditing results are unveiled about application for priority approval of medical devices (2017 NO.2)
Apr 05, 2017

According to special approval procedures for innovative medical devices (trial) (Food and Drugs Machinery-supervising (2014) No.13) by State Food and Drug Administration, the innovation medical device review office has organized the experts to review the special approval application for innovative medical devices. The following application projects have gone to special audit procedures.

1. Product name: Hydrogen oxygen nebulizer machine
Applicant: Shanghai Huimei Medical Technology Co.,Ltd
2. Product name: Human SDC2 gene methylation test kit ( fluorescence PCR)
Applicant: Guangzhou Kangliming Bio-Tech Co.,Ltd
3. Product name: Neurosurgical robot navigation and positioning system
Applicant: Huake Jingzhun (Beijing) Medical Technology Co.,Ltd
4. Product name: GNAS gene mutation detection kit
Applicant: Tianjin Jingnaite Gene Bio-Tech Co.,Ltd
5. Product name: Human EGFR gene mutation detection kit ( Multiplex fluorescence PCR)
Applicant: Xiamen Ade Bio-pharmaceutical technology Co.,Ltd
6. Product name: Human cancer multigene mutation joint test kit ( reversible end terminates the sequencing)
Applicant: Xiamen Ade Bio-pharmaceutical technology Co.,Ltd
7. Product name: Paclitaxel eluting PTCA balloon expansion catheter
Applicant: Zhejiang Barty Medical Technology Co.,Ltd
8. Product name: Abdominal aortic laminated scaffold and transmission system technology
Applicant: Minimally invasive pulse medical technology (Shanghai) Co.,Ltd
9. Product name: Renal artery radiofrequency catheter
Shanghai Minimally invasive electrophysiological care Co.,Ltd
10. Product name: Collagen cartilage regeneration vector
Applicant: Ubiosis Co.Ltd