The parties involved produced counterfeit products and failed to pass the random inspection, and were suspected of violating relevant provisions of the Product Quality Law and Trademark Law. However, trademark infringement is not an administrative violation. For counterfeiting other people’s quality marks, factory names, factory addresses and other product information, the responsibility for investigation and punishment lies not with the drug regulatory department but with the market regulatory department. Therefore, the first opinion is not inappropriate in principle. However, in reality, market regulatory authorities often regard such illegal activities in accordance with the spirit of the State Food and Drug Administration's "Notice on Matters Concerning Further Improving the Investigation and Handling of Cases" and believe that those who do not obtain approval documents or produce medical devices without a license should be punished. The first-instance responsibility system is implemented, and whoever discovers it will handle it. This leads to the embarrassing situation that the drug regulatory department is unable to investigate and deal with counterfeiting and cannot transfer it. In essence, whether Company A is counterfeiting product information such as factory name and address, or counterfeiting trademarks and other certification marks, its ultimate goal is to produce disposable medical masks. As a second category medical device, in accordance with the principle that special laws are superior to general laws, the special law "Regulations on the Supervision and Administration of Medical Devices" should be applied.

Illegal production of counterfeit masks and protective clothing is generally punished as the crime of producing and selling counterfeit and inferior products. If the sales amount is more than 50,000 yuan but less than 200,000 yuan, he or she shall be sentenced to fixed-term imprisonment of not more than two years or criminal detention, and shall also be sentenced to or A fine of not less than 50% but not more than twice the amount of sales at a single location.

Is it illegal to produce protective clothing without a license?

It is illegal. Because protective clothing is for medical use, it is very important to protect people's lives and safety. Therefore, unqualified protective clothing is neither hygienic nor safe. If used, it can easily cause casualties. Market supervision departments and public security organs in various regions will conduct an inventory of unlicensed production of medical devices within their jurisdiction based on the situation and clues from mass complaints and reports, focusing on medical device products for epidemic prevention and control, focusing on investigating and punishing the unlicensed production of medical protective clothing, medical protective clothing, etc. Illegal companies and individuals wearing masks. If a crime is suspected, the public security organs will promptly file a case for investigation in accordance with the law and hold the relevant companies and personnel criminally responsible.

Legal basis: Article 63 of the "Regulations on the Supervision and Administration of Medical Devices": In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall confiscate illegal income and medical equipment illegally produced and operated. Medical devices and tools, equipment, raw materials and other items used for illegal production and operation; if the value of medical equipment illegally produced and operated is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the value of medical equipment is more than 10,000 yuan, If the situation is serious, medical device license applications submitted by relevant responsible persons and enterprises will not be accepted within 5 years: