Beijing Beat IVD MD Technology - CFDA releases guidance on IVD reagent surveillance

The CFDA is seeking to carry out IVD reagent surveillance in order to improve product oversight, management, and use, as well as to crack down on substandard reagents or illegal manufacturing/distribution activities. This new guidance (seehttp://www.sda.gov.cn/WS01/CL0845/116947.html) will be important for companies who sell or plan to sell IVDs into China, since their reagents will be need to be robust enough to meet quality standards. Some of the key goals of the surveillance program and associated task force are to firm up reagent security and provide regulatory guidance, to undertake special investigations that protect the public health, to prevent the illegal sale of mislabeled or adulterated reagents (through quality surveillance programs), to carry out quality surveys, and to increase reagent monitoring & testing.

CFDA releases guidance on IVD reagent surveillance

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