Currently, the stock of medical masks is in a hurry, and almost all mask manufacturers are working overtime to ensure full protection. However, at this time, a small number of criminals fished in troubled waters and took the opportunity to sell fake and inferior medical masks, which seriously threatened medical and health and the lives and health of the people.

On February 4, the Information Office of the Heilongjiang Provincial Government held the seventh press conference on epidemic prevention and control in Heilongjiang Province. It was reported at the meeting that as of the 4th, the food, drug and environmental crime investigation departments of the public security organs at all levels in Heilongjiang Province had seized 24,679 counterfeit and inferior masks.

During the epidemic prevention and control period

Production and sales of fake and inferior medical masks

What kind of crime may constitute?

How will they be punished?

Recently, the National Health Commission issued the "Guidelines for the Protection of People at Different Risks of Coronavirus Infection" and "Guidelines for the Use of Pneumonia Masks for the Prevention of Novel Coronavirus Infection". There are 4 types of masks recommended, namely: disposable medical masks, Medical surgical masks, KN95\N95 and above particulate protective masks, medical protective masks.

During the SARS period in 2003, the State Food and Drug Administration promulgated the "Notice on the Classification of Medical Disposable Protective Clothing and Other Products" stipulating that from May 15, 2003, medical disposable protective clothing, medical protective masks and medical Surgical masks are classified as second-class medical devices for management. According to Article 4 of the Regulations on the Supervision and Administration of Medical Devices, the second category of medical devices are medical devices with moderate risks and require strict control and management to ensure their safety and effectiveness. It is required to obtain a medical device product registration certificate in accordance with the law when it is listed in the country, the manufacturer should obtain a medical device production license, and the operator should file for the second-class medical device operation. Therefore, the relevant national authorities have successively promulgated a series of national standards such as "Technical Requirements for Medical Protective Masks" and "Technical Requirements for Medical Surgical Masks" and the national pharmaceutical industry standards, bringing medical masks into the scope of strict management of medical devices.

· Relevant legal regulations ·

1. "Criminal Law of the People's Republic of China"

Article 145 The production of medical devices and medical sanitary materials that do not meet the national or industry standards for the protection of human health, or the sale of medical devices and medical sanitation materials that are known to be incompatible with the national or industry standards for the protection of human health, Those who seriously endanger human health shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and a fine of not less than 50% of the sales amount but not more than twice; those who cause serious harm to human health shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years, and A fine of 50% or more but not more than twice the sales amount; if the consequences are particularly serious, a fixed-term imprisonment of more than ten years or life imprisonment, and a fine of more than 50% but less than twice the sales amount or confiscation of property.

2. The Supreme People’s Court and the Supreme People’s Procuratorate Interpretation on Several Issues Concerning the Specific Application of Law in Handling Criminal Cases Concerning the Production and Sale of Fake and Inferior Commodities

Article 6 Anyone who produces or sells medical devices or medical sanitary materials that do not meet the standards and causes minor injuries or other serious consequences shall be deemed as "causing serious harm to human health" as stipulated in Article 145 of the Criminal Law. The production and sale of medical equipment and medical sanitary materials that do not meet the standards, causing incurable diseases such as viral hepatitis, serious injuries to more than one person, minor injuries to more than three persons, or other serious consequences shall be deemed as "particularly serious consequences".

The production and sale of medical equipment and medical sanitary materials that do not meet the standards, causing death, severe disability, HIV infection, serious injuries to more than three persons, minor injuries to more than ten persons, or other particularly serious consequences shall be deemed as "extraordinary circumstances" . Medical institutions or individuals who know or should know that they purchase or use medical equipment or medical sanitary materials that do not meet the national standards, industry standards for the protection of human health and cause serious harm to human health shall be the crime of selling medical equipment that does not meet the standards Conviction and punishment.

For medical devices without national or industry standards, the registered product standards can be regarded as "industry standards to protect human health."

3. The Supreme People’s Court and the Supreme People’s Procuratorate Interpretation on Several Issues Concerning the Specific Application of Law in Handling Criminal Cases Obstructing the Prevention and Control of Emergent Infectious Disease Epidemics and Other Disasters

Article 3 During the prevention and control of sudden infectious disease epidemics and other disasters, the production of medical equipment and medical sanitary materials that are used for the prevention and control of infectious diseases that do not meet the national and industry standards for ensuring human health, or the sale of which is known to be used for the prevention and control of infections Medical devices and medical sanitary materials that do not meet the national and industry standards for protecting human health, do not have the function of protection or treatment, and are sufficient to seriously endanger human health, in accordance with the provisions of Article 145 of the Criminal Law, shall be used for production, The crime of selling medical equipment that does not meet the standards is convicted and severely punished according to law.

Medical institutions or individuals who know or should know that medical devices or medical sanitary materials that do not meet the national and industry standards for the protection of human health as prescribed in the preceding paragraph have been purchased and used for compensation, and they shall be convicted of selling medical devices that do not meet the standards. Severe punishments in accordance with the law.

4. The Supreme People’s Procuratorate and the Ministry of Public Security "Regulations on Prosecution Standards for Criminal Cases Under the Jurisdiction of Public Security Organs (1)"

Article 21 The production of medical devices and medical sanitary materials that do not meet the national or industry standards for the protection of human health, or the sale of medical devices and medical sanitation materials that are known to be inconsistent with the national or industry standards for the protection of human health, are suspected of the following In one of the circumstances, the case should be filed for prosecution:

(1) The materials of medical devices that enter the human body contain toxic and harmful substances exceeding the standard;

(2) The effectiveness index of the medical device that enters the human body does not meet the standard requirements, resulting in partial or complete loss of the treatment, substitution, adjustment, and compensation functions, which may cause misdiagnosis and treatment or serious human body injury;

(3) The safety indicators of active medical devices used for diagnosis, monitoring, and treatment do not meet the requirements of mandatory standards and may cause harm or potential harm to the human body;

(4) The main performance indicators of active medical devices used for diagnosis, monitoring, and treatment are unqualified, which may cause misdiagnosis and treatment or serious human body injury;

(5) Unauthorized addition of functions or scope of application without approval may cause misdiagnosis and treatment or serious injury to the human body;

(6) Other situations that are sufficient to seriously endanger human health or cause serious harm to human health.

If a medical institution or individual knows or should know that it is a medical device or medical sanitary material that does not meet the national or industrial standards for the protection of human health and purchases and uses it for a fee, it shall be regarded as "sale" as prescribed in this article.

·Judicial identification ·

1. The perpetrator produces medical masks that do not meet the national or industry standards for protecting human health, or sells medical masks that are known to be incompatible with the national or industry standards for protecting human health, and are sufficient to seriously endanger human health, to be produced and sold Conviction and punishment for the crime of medical equipment that does not meet the standards; if the above-mentioned acts constitute this crime during the prevention and control of sudden infectious disease epidemics and other disasters, he shall be punished severely in accordance with the law.

2. Medical institutions or individuals who know or should know that they are medical masks that do not meet the national or industry standards for protecting human health and buy and use them for a fee, which cause serious harm to human health, shall be convicted of selling medical equipment that does not meet the standards Punishment; if the above-mentioned conduct constitutes this crime during the prevention and control of sudden infectious disease epidemics and other disasters, he shall be punished severely in accordance with the law.

3. If the act of producing or selling fake and inferior medical masks has not yet constituted the crime of producing or selling medical equipment that does not meet the standards, but the sales amount is more than 50,000 yuan, the crime of producing and selling fake and inferior products shall be convicted and punished.

4. During the prevention and control of sudden infectious disease epidemics and other disasters, the production and sale of fake and inferior protective equipment, such as masks other than medical masks, constitutes a crime, and shall be convicted of the crime of producing and selling fake and inferior products and be severely punished in accordance with the law.

· Case link ·

1. The production of medical devices and medical sanitary materials that do not meet the national and industry standards to protect human health is enough to seriously endanger human health and constitutes the crime of producing non-compliant medical devices-Li and Song do not meet the standards Medical equipment case

Summary of the case: The perpetrator produced medical degreased gauze squares, medical degreased bandages and other medical sanitary materials that did not meet the national standards and industry standards, which were enough to seriously endanger human health. According to the provisions of Article 145 of the Criminal Law, the production did not meet the standards Convicted and punished for the crime of medical equipment.

Case No.: (2014) Lu Xing Chu Zi No. 109

Trial court: People's Court of Luyi County, Henan Province

Case source: China Judgment Document Network

2. Selling medical devices and medical sanitary materials that are known to be inconsistent with the national and industry standards for protecting human health, which are enough to seriously endanger human health, constitute the crime of selling medical devices that do not meet the standards-Zhang, Xia, etc. Cases of non-compliant medical equipment

Summary of the case: The perpetrator knew that the contact lens he purchased was a medical device that did not meet the national standards for the protection of human health. However, he still sold it, which was enough to seriously endanger human health. According to the provisions of Article 145 of the Criminal Law, the sales were not in compliance The standard medical device crime is convicted and punished.

Case number: (2016) Su 1181 Xing Chu No. 437

Trial court: People's Court of Danyang City, Jiangsu Province

Case source: China Judgment Document Network

3. The sale of counterfeit and shoddy products by a seller who pretends to be inferior or substandard products as qualified products and the sales amount reaches the legal standard constitutes the crime of selling counterfeit and shoddy products-Li and Pan selling counterfeit and shoddy products

Summary of the case: The perpetrator knew that the color ultrasound equipment involved in the case was a counterfeit and inferior product and sold it. The sales amount reached 1.38 million yuan. According to the provisions of Article 140 of the Criminal Law, the perpetrator was convicted and punished for the crime of selling counterfeit and inferior products.

Case number: (2019) Lu 13 Xing Zhong No. 248

Trial court: People's Court of Linyi City, Shandong Province

Case source: China Judgment Document Network

Recently, Heilongjiang Higher People's Court also issued

(Click the text to jump to the link)

Strictly punish 9 categories of 36 criminal crimes involved in epidemic prevention and control in accordance with the law

Among them are the crimes of producing and selling fake and inferior goods

In short, the epidemic is currently

Please standardize operations

Otherwise, for criminals

Will be severely punished!