A, unlicensed sales of medical equipment how to punish
For the unlicensed sales of medical equipment, the drug supervision and management department at or above the county level ordered to stop the business, confiscate the illegal operation of the product and the illegal income, the illegal income of more than five thousand yuan, and impose a fine of more than twice the illegal income of more than five times the fine; no illegal income or illegal income of less than five thousand yuan, and impose a fine of more than five times the illegal income; no illegal income or illegal income of less than five thousand yuan, and impose a fine of less than five times the illegal income. Less than five thousand yuan, and impose a fine of five thousand yuan or more than 20,000 yuan; constitutes a crime, be held criminally responsible. "Supervision and Administration of Medical Devices Regulations" Article 63 of the following circumstances, by the people's governments at or above the county level, food and drug supervision and management department shall confiscate the illegal income, illegal production and operation of medical devices and for the illegal production and operation of tools, equipment, raw materials and other items; illegal production and operation of medical devices less than 10,000 yuan of the value of the goods and impose 50,000 yuan of 100,000 yuan of fines; the value of 1,000 yuan of goods and impose 50,000 yuan of fines. Fines; value of more than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the following fine; the circumstances are serious, within five years not to accept the relevant responsible person and the enterprise to apply for a medical device license: (a) the production and operation of medical devices without obtaining the certificate of registration of the second class, the third class of medical devices; (b) unauthorized to engage in the production of the second class, the third class of medical equipment activities (C) unauthorized to engage in Class III medical device business activities. The first paragraph of the previous situation, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license. Unauthorized use of large medical equipment configuration, by the people's governments above the county level, the competent department of health ordered to stop the use of health, give a warning, confiscate the illegal income; illegal income of less than 10,000 yuan, and impose a fine of 10,000 yuan or more than 50,000 yuan; more than 10,000 yuan of illegal income and impose a fine of more than five times the illegal income of 10 times the following; the circumstances are serious, the responsible person and the unit will not be admitted for five years Proposed large medical equipment configuration license application.Second, the conditions of the medical device agent
should have the conditions of the medical device agent: 1, the operation of medical equipment documentation requirements: "Medical Device Business License / Permit Application Form" four copies of the applicant's qualification certificate copy of the name of the medical device business pre-approval notice. 2, personnel requirements: the person in charge of operating medical devices business should have a college degree or above to familiarize with the relevant laws and regulations of medical devices. At the same time, the person in charge of the enterprise, quality management personnel, quality inspection personnel can not be part-time other positions. Quality management personnel must have a college degree or above with more than one year of work experience. 3, office space and warehouse requirements: the business of medical equipment companies require office space for non-residential areas. Reagents use an area of not less than 60 square meters. Warehouse requirements for non-residential area of not less than 20 square meters for some of the products required to reach more than 100 square meters and the requirements of light, ventilation, dust, insect, moisture, rodent, pollution prevention, fire safety, testing and temperature and humidity adjustment facilities and equipment, as well as lighting facilities to meet the requirements. Storage of the implementation of zoning and classification management clearly marked and stored according to the product batch. The storage area should be divided into areas to be inspected, qualified products area, shipping area, non-qualified products area and other specialized places. 4, health management system and after-sales service system requirements: the operation of medical equipment companies should establish a sound health management system to ensure product safety in addition to the enterprise should have its business with the medical device products appropriate technical training and after-sales service capabilities or agreed by the third party to provide technical support.