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Public Notice of the Review Results for Priority Approval Applications for Medical Devices (No. 4, 2017)
In accordance with the "Procedures for Priority Review of Medical Devices" (Announcement No. 168 of 2016 of the China Food and Drug Administration), our Center has reviewed the applications for priority review of medical device registration. The following items meet the criteria for priority review and are proposed to be granted priority review status. They are hereby published for public notice.
| No. | Application No. | Product Name | Applicant | Reason for Consent |
| 1 | CQZ1700312 | Hernia Repair Mesh | Beijing Biosis Healing Biological Technology Co.,Ltd | Included in the National Key Research and Development Program |
| 2 | CQZ1700331 | Thoracic Aortic Stent Graft System | Beijing Percutek Therapeutics Medical Equipment Co., Ltd. | Included in the National Key R&D Program |
| 3 | CQZ1700334 | Gene Sequencer | Wuhan MGI Tech Co., Ltd. | Included in the National Key Research and Development Program |
Public Notice Period: August 15, 2017 to August 21, 2017
During the public notice period, any entity or individual with objections may complete the Objection Form for Priority Review Projects of Medical Devices and submit it in writing to the General Business Division of our Center.
Contact: Xu Liang
Tel: 010-86452911
Email: xuliang@cmde.org.cn
Address: Room 202, No. 55 Xiwai Taipingzhuang, Haidian District, Beijing
China Food and Drug Administration
Center for Medical Device Technical Evaluation
August 15, 2017
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