The State Drug Administration of the new coronavirus test reagents as a third class medical device management. Enterprises are the main body of the third class medical device business, and must obtain a medical device business license, individuals can not engage in the third class medical device (including the second class) business activities. Therefore, individuals in the circle of friends and other online platforms to sell the new crown antigen kit is illegal, if the reagent appears to be counterfeiting, to unqualified products as qualified products, the circumstances are serious can be sentenced to life imprisonment.
The State Drug Administration then classified the new coronavirus test reagents as Class III medical devices. The state classifies and manages medical devices according to the level of risk, and Class III is a medical device that has a higher risk and requires special measures to strictly control and manage to ensure its safety and effectiveness.
Individuals selling antigen reagents privately is illegal, if the reagent appears to be counterfeiting, in order to unqualified as qualified, the seriousness of the situation can be sentenced to life imprisonment; some manufacturers also on the phenomenon of selling antigen reagents privately issued a disclaimer; more than one high school, public security, the market supervision department issued a voice to rectify the illegal sale of antigens mess.