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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