Legal analysis: 1, for the unlicensed business behavior, by the administration for industry and commerce shall be banned according to law, confiscate the illegal income; criminal law, in accordance with the criminal law on the crime of illegal business, the crime of major accidents, the crime of major labor safety accidents, the crime of hazardous materials, or other crimes, according to law, the investigation of criminal responsibility;
2, is not enough to criminal penalties, and impose a 20,000 yuan The following fine; unlicensed operation of a larger scale, serious social hazards, and impose a fine of 20,000 yuan more than 200,000 yuan;
3, unlicensed operation of human health hazards, the existence of significant safety hazards, threats to public **** safety, damage to environmental resources, confiscate tools, equipment, raw materials, products (commodities) and other property used exclusively to engage in unlicensed operation, and impose a fine of more than 50,000 yuan 500,000 yuan fine.
Legal basis: "Medical Device Supervision and Administration Regulations"
Article 81 In one of the following cases, the department in charge of drug supervision and management shall confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation of the goods; illegal production and operation of medical devices of less than 10,000 yuan of the value of the goods, and impose a fine of 50,000 yuan or more than 15 million yuan; the value of the goods is less than 10,000 yuan, and impose a fine of 50,000 yuan or more than 15 million yuan. The value of goods amounting to more than 10,000 yuan, and impose a value of more than 15 times the amount of 30 times the amount of fines; the circumstances are serious, ordered to suspend production and business, 10 years will not be accepted by the person responsible for the unit and the unit of medical device license application, the legal representative of the unit, the main person in charge of the unit directly responsible for supervisors and other responsible personnel, confiscation of the period of the illegal act from the unit of income, and impose a penalty of 30% of the income earned from the unit of the illegal act. Income, and impose a fine of more than 30% of the income obtained more than three times the lifetime ban on the production and operation of medical equipment activities:
(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of medical devices of the second and third class of production activities;
(c) unauthorized to engage in the third class of medical devices business activities. Medical device business activities.
The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.
Article 82 unauthorized configuration and use of large-scale medical equipment, by the people's governments at or above the county level, the competent department of health ordered to stop the use of warning, confiscate the illegal income; illegal income of less than 10,000 yuan, and impose a fine of 50,000 yuan to 100,000 yuan; illegal income of 10,000 yuan or more, and impose a fine of more than 10 times the illegal income of more than 30 times the following fine; the circumstances are serious, within five years Do not accept the relevant responsible person and the unit of large-scale medical equipment configuration license application, the legal representative of the illegal unit, the main person in charge, directly responsible for the competent personnel and other responsible persons, confiscate the illegal behavior during the period of time from the unit's income, and impose a fine of more than 30% of the income obtained more than three times, and shall be punished according to law.
Article 83 in the application for administrative licensing of medical devices to provide false information or take other deceptive means, shall not be administratively licensed, has been obtained by the administrative licensing decision by the administrative licensing department to revoke the administrative license, confiscate the illegal income, the illegal production and operation of the use of medical devices, 10 years will not be accepted within the relevant responsible person and the unit of the application for licensing of medical devices; illegal production and operation of the use of medical devices the value of the value of the confiscation of illegal production and operation of medical devices, shall be given a fine of 30% of the income. Production and operation of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan more than 150,000 yuan; value of more than 10,000 yuan, and impose a fine of 15 times the value of more than 30 times the amount of the following; the circumstances are serious, shall order the suspension of production and shutdown of the illegal unit of the legal representative, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscation of the illegal behavior during the period of time from this unit The income obtained during the violation, and impose a fine of more than 30% of the income obtained more than three times the following fine, a lifetime ban on their engagement in the production and operation of medical equipment activities.
Forgery, alteration, trading, leasing, lending of relevant medical device license shall be seized or revoked by the original licensing department, confiscate the illegal income; illegal income of less than 10,000 yuan, and impose a fine of 50,000 yuan to 100,000 yuan; illegal income of 10,000 yuan or more and impose a fine of 10 times the illegal income of more than 20 times the fine; constitute a violation of law and order management, the public security organs shall be punished according to law. shall be punished by the public security administration according to law.