On March 30th, 2020, the State Administration of Pharmaceutical Products issued the Supervision Requirements and Standards for Testing Reagents and Protective Articles in novel coronavirus, China, and listed the testing reagents in novel coronavirus as the third category of medical device management.
In March this year, the State Administration of Medical Devices issued the Notice on Doing a Good Job in Quality and Safety Supervision of Antigen Detection Reagents in COVID-19, requiring retail pharmacies and medical device enterprises that have obtained the Drug Business License or the Medical Device Business License and have corresponding storage conditions to sell COVID-19 Antigen Detection Reagents.
According to the information of Sky Eye Survey, many companies have recently been fined for illegally selling COVID-19 antigen detection reagents. Among them, a logistics company in Shanghai bought antigen kits at the price of 5. 15 yuan/person without permission, and then sold them at the price of 10 yuan/person, and sold 46 copies of 460 yuan, and was fined 50,000 yuan, and the illegal income was confiscated.
Fu Jian, director of Henan Jinze Law Firm, said that COVID-19 virus detection reagents belong to the third category of medical devices, and it is illegal for unqualified individuals to sell them privately. The pharmaceutical supervisory and administrative department at or above the county level shall order it to stop its business operation, confiscate the illegally operated products and illegal income, and impose a fine of more than two times and less than five times the illegal income if the illegal income is more than 5,000 yuan; In addition to administrative punishment, if it involves disrupting market order and the circumstances are serious, it may be suspected of illegal business operations. If the amount of illegal business operation exceeds 50,000 yuan, or the illegal income exceeds 1 10,000 yuan, which reaches the standard of criminal prosecution, the public security organ shall file a case for investigation.
Fu Jian said that if the antigen reagents sold privately are fake and shoddy products, or fake and genuine products are passed off as qualified products with unqualified products, and the sales amount is large, it is also suspected of producing and selling fake and shoddy products. According to the criminal law, if the sales amount exceeds 2 million, the maximum penalty is life imprisonment, a fine of more than 50% and less than 2 times the sales amount, or confiscation of property.