Legal analysis: 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 warnings, confiscate the illegal income; illegal income of less than 10,000 yuan and impose a fine of 50,000 yuan more than 100,000 yuan; more than 10,000 yuan of illegal income 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 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 from the unit during the period of income, and impose a fine of more than 30% of the income obtained more than three times the amount of punishment in accordance with the law.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 86 One of the following circumstances, by the drug supervision and management department responsible for ordering correction, confiscation of illegal production and operation of medical devices; illegal production and operation of medical devices less than 10,000 yuan, and impose a fine of 20,000 yuan or more than 50,000 yuan; more than 10,000 yuan of the amount of the amount of the value of goods and impose a fine of five times the amount of goods and impose a fine of 20 times; the circumstances are serious. More than 20 times the amount of fines; the circumstances are serious, ordered to suspend production and business, until the original licensing department to revoke the medical device registration certificate, medical device manufacturing license, medical device license, the legal representative of the illegal unit, the main person in charge, directly responsible for the supervisors and other responsible personnel, confiscate the illegal behavior from the unit during the income earned, and impose more than 30% of the income earned more than three times the amount of fines, 10 years prohibited from engaging in medical treatment, and the use of medical devices. Fines, within 10 years prohibited from engaging in the production and operation of medical devices: (a) the production, operation and use of medical devices do not meet the mandatory standards or do not meet the technical requirements of the registered or filed products; (b) not in accordance with the technical requirements of the registered or filed products to organize the production, or not in accordance with the provisions of these Regulations to establish a quality management system and maintain effective operation, affecting the safety of the product, effective; (c) the operation, use, without proof of qualification document. (C) the operation and use of medical devices without qualification documents, expired, invalid, obsolete, or the use of medical devices not registered in accordance with law; (D) in the drug supervision and management department responsible for ordering the recall of the recall, or in the drug supervision and management department responsible for ordering the cessation or suspension of the production, import and operation, but still refused to stop the production, import and operation of medical devices; (E) entrusted enterprises that do not have the conditions stipulated in the regulations to produce medical equipment; (F) the production of medical devices in accordance with the provisions of the regulations. Provisions of the conditions of the enterprise production of medical devices, or not entrusted to the production of enterprise production behavior management; (F) the import of expired, invalid, out of use and other medical devices have been used.