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:
Reason of Approval
ELISA kit for specific cellular immune response of Mycobacterium tuberculosis (enzyme-linked immunosorbent assay)
Guangzhou Leide Biotechnology Co., Ltd.
Intended product is included as the
National science and technology major project of medical devices
Factor VIII dosing guidance software
Baxalta US Inc.
Intended product is regarded as the urgent need in clinical setting, and there is no relevant approved medical device in China.