March 30, 2020, the State Drug Administration issued "China's regulatory requirements and standards for new coronavirus testing reagents and protective equipment," the new coronavirus testing reagents as a third class of medical device management.
In March this year, the State Drug Administration issued the Notice on Doing a Good Job in Supervising the Quality and Safety of New Coronavirus Antigen Detection Reagents, which requires that retail pharmacies and medical device operators that have obtained a drug business license or medical device business license and have the appropriate storage conditions be allowed to sell new coronavirus antigen detection reagents.
Tianyecha information shows that a number of companies have recently been fined for selling new coronavirus antigen test reagents in violation of the law. Among them, a logistics company in Shanghai without permission to buy antigen reagent kits at a price of 5.15 yuan per person, and then sell them to the public at a price of 10 yuan per person, selling 46 copies of *** counting 460 yuan, was fined 50,000 yuan and confiscated the illegal income.
On Dec. 7, the Chaoyang District Market Supervision Bureau received a report that it had opened an investigation into the high-priced sale of antigen kits at the Chaoyang No. 1 branch of Beijing Rehabilitation Home Medical Supplies Co.
Fu Jian, director of Henan Zegen Law Firm, said the new coronavirus test reagent belongs to the third class of medical devices, and it is illegal for unqualified individuals to sell it privately. By the county-level or above drug supervision and management department ordered to stop operating, confiscate the illegal operation of the product and illegal income, illegal income of more than five thousand yuan, and impose a fine of more than two times the illegal income of more than five times the following; in addition to administrative penalties, if it involves disrupting the market order, the circumstances are serious, may be suspected of illegal business crime, illegal business amount of more than 50,000 yuan, or more than 10,000 yuan of illegal income, has Reached the standard of prosecution of criminal offenses, should be investigated by the public security organs.
Fu Jian said, if the private sale of antigen reagents are counterfeit products, or fake for real, substandard products as qualified products, and the sales amount is large, but also suspected of production and sale of shoddy products crime. According to the Criminal Law, if the sales amount exceeds two million, the maximum penalty is life imprisonment and a fine of not less than fifty percent and not more than two times the sales amount, or confiscation of property.
The public election king noted that a number of places for people to sell epidemic-related medical products privately has been carried out corresponding measures. Among them, Baoding Municipal Market Supervision Bureau of Hebei Province, the Municipal Public Security Bureau, but also issued "on the fight against epidemic prevention and control during the illegal and criminal acts involving drugs and medical devices," which provides that individuals are strictly prohibited from operating drugs and medical devices in any form.