If you go through the approval procedures in accordance with the law when operating medical alcohol, it will not be a crime; if you do not go through the relevant procedures and operate without authorization, it will be a crime. If the market order is disrupted, and the circumstances are serious, it will also constitute the crime of illegal business operations.

Legal analysis

It should be determined based on the product approval certificate number. The business scope of 75% alcohol is generally sanitation and disinfection, Class I medical devices and Class II medical devices. According to the laws and regulations of our country, medical device operations are subject to classified management according to the risk level of medical devices. The operation of Class I medical devices does not require licensing and registration, the operation of Class II medical devices is subject to registration management, and the operation of Class III medical devices is subject to licensing management.

When operating hygienic and disinfectant alcohol, the following valid certificates should be obtained:

(1) A copy of the production enterprise’s health license;

(2) Product registration certificate Or a copy of the health license approval document.

Copies of valid certificates should be stamped with the seal of the original holder.

Article 32 of the "Disinfection Management Measures" prohibits the production and operation of the following disinfection products:

(1) Without a production enterprise health license or a new disinfection product health license approval document;

(2) The product hygiene and safety evaluation fails or the product hygiene quality does not meet the requirements.

Article 4 of the "Measures for the Supervision and Administration of Medical Device Operations" stipulates that medical device operations shall be managed according to the risk level of the medical device.

The operation of Class I medical devices does not require licensing and registration, the operation of Class II medical devices is subject to filing management, and the operation of Class III medical devices is subject to licensing management.

Legal Basis

Article 225 of the Criminal Law of the People's Republic of China and the People's Republic of China Violates state regulations, commits one of the following illegal business activities, disrupts market order, and the circumstances If the case is serious, the offender shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention, and shall also or solely be fined not less than one time but not more than five times the illegal income; if the circumstances are particularly serious, he shall be sentenced to fixed-term imprisonment of not less than five years or criminal detention, and shall also be fined not less than one time but not more than five times the illegal income. Or confiscation of property: (1) Operating franchises, monopoly items or other restricted items stipulated in laws and administrative regulations without permission; (2) Buying and selling import and export licenses, import and export certificates of origin, and other laws and administrative regulations. (3) Illegal operations of securities, futures, and insurance businesses without approval from relevant state authorities, or illegal fund payment and settlement business; (4) Other illegal business activities that seriously disrupt market order .