Legal analysis: the operation and use of no qualification documents, expired, invalid, obsolete medical devices, or the use of medical devices not registered in accordance with the law, by the department responsible for drug supervision and management shall order correction, confiscation of illegal production, operation and use of medical devices; illegal production, operation and use of medical devices less than 10,000 yuan of the value of the amount of the fine of 20,000 yuan or more than 50,000 yuan; the amount of the amount of more than 10,000 yuan, and impose more than 5 times 20 times the fine; the circumstances are serious, shall order the suspension of production and business, until the original licensing department revoke the registration of medical devices, medical devices, and 20 times the penalty. The value of more than 10,000 yuan, and impose a value of more than 5 times the amount of 20 times the following fine; the circumstances are serious, ordered to suspend production and business, until the original licensing department to revoke the medical device registration certificate, medical device production license, medical device license, the legal representative of the illegal unit, the main person in charge of the unit directly responsible for supervisors and other responsible personnel, confiscation of the illegal act from the unit of the income earned during the period of time, and The penalty of 30% of the income obtained from more than three times the following fine, 10 years prohibited from engaging in the production and management of medical devices
Legal basis: "supervision and management of medical devices regulations" Article 86 of one of the following circumstances, the department responsible for the supervision and management of drugs shall order rectification, confiscation of illegal production and operation of medical devices; illegal production and operation of medical devices used in the value of less than 10,000 yuan If the amount of the value of the goods is less than 10,000 yuan, and impose a fine of 20,000 yuan or more than 50,000 yuan; the value of more than 10,000 yuan, and impose a fine of 5 times the amount of the value of the goods or more than 20 times the amount of the following fine; the circumstances are serious, shall be ordered to suspend production and business, or by the original licensing department to revoke the certificate of registration of medical devices, medical device manufacturing licenses, medical device license, the illegal units of the legal representative, the principal person in charge of the competent person directly responsible for the competent person and other responsible personnel The illegal behavior of the unit during the period of confiscation of income from the unit, and impose a fine of more than 30% of the income obtained more than three times the following fine, 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 products by the registration or filing; (b) failure to comply with the registration or filing of the products by the organization of the technical requirements of the production, or failure to In accordance with the provisions of these Regulations to establish a quality management system and maintain effective operation, affecting product safety and effectiveness; (C) the operation and use of no qualification documents, expired, invalid, out of medical devices, or the use of medical devices not registered in accordance with the law; (D) in the drug supervision and management department responsible for ordering the recall is still refusing to recall, or in the drug supervision and management department responsible for ordering the cessation or suspension of production, Import, operation, but still refused to stop the production, import, operation of medical devices; (E) entrusted to do not have the conditions set out in these regulations of the enterprise production of medical devices, or not entrusted to the production of enterprises to manage the production behavior; (F) the importation of expired, expired, eliminated, etc., have been used in the medical equipment.