The circumstances are serious, ordered to suspend production and business, until the original licensing department to revoke the certificate of registration of medical devices, medical device manufacturing license, medical device license, the legal representative of the offending unit, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscate the illegal behavior during the period of time from the unit of the income gained and impose a fine of more than 30% of the income gained more than three times, the following. 10 years prohibited from engaging in the production and operation of medical devices.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 86
Any of the following circumstances, the department in charge of drug supervision and management shall order correction and confiscation of the illegal production and operation of the use of medical devices; the illegal production and operation of the use of medical devices of less than 10,000 yuan, and impose a fine of 20,000 yuan. The value of 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 value of more than 20 times the value of the fine; the circumstances are serious, and ordered to suspend production and business, until the original licensing department revoke the registration of medical devices, medical device production license, medical device license, the legal representative of the illegal unit, the main person in charge of the unit, the supervisors directly responsible for the unit, and other responsible personnel, confiscated during the period in which the violation occurs. Responsible personnel, confiscate the illegal behavior during the period from the unit's income, 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, use does not meet the mandatory standards or does not meet the technical requirements of the products by the registration or filing of the medical device;
(b) failure to comply with the technical requirements of the products by the registered Or the record of the product technical requirements of the organization of production, or not 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 medical devices without documents of conformity, expiration, expiration, elimination, or the use of medical equipment is not registered in accordance with the law;
(D) in the drug supervision and management authorities responsible for the order to recall After the recall still refuses to recall, or in charge of drug supervision and management departments ordered to stop or suspend the production, import, operation, but still refuses to stop the production, import, operation of medical devices;
(E) entrusted to do not have the conditions set out in the Regulations for the production of medical devices, or not entrusted to the production of enterprises to manage the production of behavior;
(F) the importation of expired, expired, obsolete and other Has been used medical devices.