1, the sale of expired medical devices have not been used, the confiscation of the medical devices involved, the value of less than 10,000 yuan, a fine of 20,000 yuan more than 50,000 yuan;
2, the sale of expired medical devices have been used, the confiscation of the illegal products and the illegal income, the illegal income of 5,000 yuan or more, the fine of more than twice the illegal income of five times The illegal income is less than 5,000 yuan, a fine of 5,000 yuan more than 20,000 yuan;
3, the circumstances are serious, may be ordered to suspend production and business.
Classification of medical devices:
1, according to the risk level, medical devices are divided into class I (low risk), class II (medium risk) and class III (high risk);
2, class I medical devices usually include general daily necessities and instruments, such as medical bandages, surgical gowns, etc.
3, class II medical devices include products that require certain control to ensure their safety and effectiveness. to ensure its safety and effectiveness of the products, such as X-ray machines, ultrasound diagnostic equipment, etc.;
4, Class III medical devices are potentially high-risk products for the human body, usually need pre-market approval, such as pacemakers, artificial joints, etc..
In summary, the penalties for selling expired medical devices vary according to whether they are used and the amount of illegal income: when they are not used, the devices will be confiscated and a fine of 20,000 to 50,000 yuan will be imposed; when they have been used, the products and proceeds will be confiscated, and fines will be imposed in different multiples according to the amount of proceeds; and those with serious cases will face the penalties of shutting down the production and business.
Legal basis:
"Regulations for the Administration of Medical Devices"
Article 42
Violation of the provisions of these regulations, medical institutions use no product registration certificate, no certificate of conformity, expired, expired, eliminated medical devices, or from the absence of the "Medical Device Manufacturer's License", "Medical Device Operator's License" of the enterprise to purchase Medical devices, by the people's government at or above the county level drug supervision and management department shall order correction, give a warning, confiscate the illegal use of the product and illegal income, illegal income of more than 5000 yuan, and impose a fine of more than two times the illegal income of less than five times; no illegal income or illegal income of less than 5,000 yuan and impose a fine of more than 5,000 yuan of 20,000 yuan; on the supervisory personnel and other directly responsible personnel shall be given disciplinary sanctions according to law. Responsible persons shall be given disciplinary action according to law; constitutes a crime, shall be investigated for criminal responsibility.