CFDA approved PD-L1 test kit, by Dako North America, though Priority Review pathway, on the ground of Unmet Medical Needs and No Approved Alternatives Exist. This is the only IVD greenlighted by CFDA Priority Review in September.
For list of Priority Review devices/IVDs in 2018, please email info@ChinaMedDevice.com.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------