Lobby Letter to Drug Registration Department of the CFDA on Registration of Chemoluminescent Blood Screening Products
2016-05-11 | Beijing
Chemoluminescent blood screening products are an advanced tool to diagnose antigens in fluids and may be used for detection of infectious diseases, incl. HIV.
The WHO recommends chemoluminescent blood screening products as one of the standard diagnosis methods, also the Chinese NHFPC plans to use this diagnostics.
In Europe chemoluminescent blood screening products are registered as medical devices, in the USA as Pharmaceutical Products. In China the CFDA has defenitly rejected to register these products as medical devices.
Therefore the European Chamber asks the Drug registration departments to clear the necessary procedures to register these diagnostics as pharmaceutical products.
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