The auditing results are unveiled about application for priority approval of medical devices (2017 No.2)
Release time:2017/04/05       Pageviews:1444

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

Publicity time: March 7, 2017 to March 20

During publicity, ff any unit or individual has any objection, it may be reported to central comprehensive business unit by means of written, telephone or email.

Contact person: Liang XU

Telephone: 010-68390674

Fax: 010-68390777

E-mail: xuliang@cmde.org.cn

Address: Room 301, Building B3, No.9, Chegongzhuang Street, Xicheng district, Beijing

State Food and Drug Administration

China Medical Device Evaluation

March 7, 2017