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Official CMDE’s Announcement on the Review Result for Special Approval Application in Innovative Medical Device and Priority Approval Application (Published on April 24th,2019)
2019-05-09 14:11

According to the "Priority Approval Procedure for Medical Devices" (Order No. 168, 2016) of National Medical Product Administration (NMPA), Center for Medical Device Evaluation (CMDE) published the review result of the special approval application for innovative medical devices and priority approval application which are complied with requirements for priority approval.

The detailed information of approved products is listed as following:

Case Number

Product Name

Company

Reason of Approval

CSZ1900135

ELISA kit for   specific cellular immune response of Mycobacterium tuberculosis   (enzyme-linked immunosorbent assay)

结核分枝杆菌特异性细胞免疫反应检测试剂盒(酶联免疫法)

Guangzhou Leide   Biotechnology Co., Ltd.

Intended product is   included as the

National science and   technology major project of medical devices

JQZ1900118

Factor VIII dosing   guidance software

百因止剂量指导软件

Baxalta US Inc.

Intended product is   regarded as the urgent need in clinical setting, and there is no relevant   approved medical device in China.

 

 

 


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