Since the outbreak of NCP, medical masks have become a must-have for all people. For example, the office of the Prevention and Control Command of NCP in Guangdong, issued a notice as early as 26 January 2020, requiring everyone to wear a mask in public places (please check our previous post for more details: CNY Holiday Extension & Updates on Curbing Virus Outbreak.)

Of course, the masks to be donned are not ordinary masks. There are strict product quality standards and requirements for companies to manufacture or sell them. Let’s take a closer look at these rules:

1. Quality requirements for medical masks

Medical masks are different from ordinary masks. Generally speaking, according to their product standards, such as non-oil particle filtration efficiency, air flow resistance, filtration efficiency, bacterial filtration efficiency and respiratory resistance etc., medical masks can be divided into three types:

a) medical protective masks;

b) medical surgical masks; and

c) general medical masks.

Different product standards will be applied respectively, which are “Medical Protective Mask Technical Requirements” (GB19083), “Medical Surgical Mask Technical Requirements” (YY0469) and “One-time Use of Medical Masks ” (YY/T0969).

The third type masks,  “general medical masks” refer to all medical masks, the name of which does not contain “protection” or “surgical”. This type of masks is only used in medical environments.

In addition, the product manual should clarify whether to implement the above mentioned three product standards, the scope of application of the product must be consistent with the product standards applied. Filter level, storage period, whether it is for one-time use should also be clarified on the packaging.

2. Company requirements to produce or sell medical masks

At present, according to the revised “Medical Device Classification Catalog” issued by the former State Administration of Food and Drug Administration (now merged into the State Administration for Market Regulation) on 31 August 2017, medical masks fall under the second category of medical devices. In accordance with the “Regulations on the Supervision and Administration of Medical” Devices (2017 Amendment), companies engaged in the operation of producing or dealing with medical masks shall file a record with the food and drug supervision and administration department of the local government, otherwise they shall not engage in such business activities.

3. Legal responsibility of producing or selling counterfeit and inferior medical masks

According to China’s relevant laws, the act of manufacture or sale of counterfeit medical masks that cannot provide effective protection is illegal and even constitutes a criminal offense.
Article 49 of the “Product Quality Law of the People’s Republic of China” stipulates:

“If the products of a producer or seller do not comply with the national or industry standards for protection of health or personal safety or the safety of property, orders shall be issued to cease their production or sale. Products that have been illegally produced or sold shall be confiscated. A fine shall be imposed equal to an amount greater than the value of the products that have been illegally produced or sold (hereafter including products already sold and goods not yet sold) but less than three (3) times the value of the products; where there is illegal income, the illegal income shall be confiscated; where the circumstances are serious, the business license shall be revoked; where the case constitutes a crime, criminal liability shall be pursued in accordance with law.”

In addition, the manufacture and sale of counterfeit and inferior medical masks also violates the provisions of Article 145 of the “Criminal Law of the People’s Republic of China”:

“Whoever produces medical appliances or medical hygiene materials that do not conform to the national or trade standards safeguarding human health, or sells such appliances or materials while clearly knowing their inconformity to the national or trade standards safeguarding human health, and thereby causes serious harm to human health, shall be sentenced to fixed-term imprisonment of not more than five years, and concurrently be sentenced to a fine of not less than half of the sum obtained through sale and not more than twice of the sum. If the consequences are especially serious, the offender shall be sentenced to fixed-term imprisonment of not less than five years and not more than ten years, and concurrently be sentenced to a fine of not less than half of the sum obtained through sale and not more than twice of the sum; the offender whose circumstances are especially flagrant shall be sentenced to fixed-term imprisonment of not less than ten years or life imprisonment, and concurrently be sentenced to a fine of not less than half of the sum obtained through sale and not more than twice of the sum or confiscation of property.”

Lastly, according to the guidance issued by the Supreme People’s Procurator on the “Handling of Criminal Cases during the Prevention and Control of NCP” issued on 30 January 2020, criminal acts that endanger the prevention and control of the epidemic and seriously disturb the social order will be dealt with strictly in accordance with the law.