1, for unlicensed sales of medical devices, the pharmaceutical supervisory and administrative department at or above the county level shall order it to stop operating, confiscate the illegally operated products and illegal income, and impose a fine of more than one time but less than five times the illegal income;
2. If there is no illegal income or the illegal income is less than 5,000 yuan, a fine ranging from 5,000 yuan to 20,000 yuan shall be imposed;
3, constitute a crime, shall be investigated for criminal responsibility according to law.
Unlicensed operation refers to the act of engaging in business activities without obtaining a license issued by the licensing examination and approval department in accordance with the provisions of laws and regulations, without applying for industrial and commercial registration with the administrative department for industry and commerce, and obtaining a business license.
Medical device agency requirements:
1. Documentation requirements for operating medical devices: application form for medical device business license in quadruplicate, copy of applicant's qualification certificate, and notice of pre-approval of medical device business name.
2. Personnel requirements: the person in charge of the medical device enterprise should have a college degree or above and be familiar with the relevant laws and regulations of medical devices. At the same time, the person in charge of the enterprise, quality management personnel and quality inspection personnel cannot hold other positions concurrently. Quality management personnel must have a college degree or above and more than one year's work experience.
3. Requirements for office space and warehouse: The office space of medical device enterprises is required to be a non-residential area. The reagent use area is not less than 60 square meters.
Legal basis:
Regulations on the supervision and administration of medical devices
Article 81, paragraph 1, item 3
Under any of the following circumstances, the pharmaceutical supervisory and administrative department shall confiscate the illegal income, medical devices illegally produced and operated, and tools, equipment, raw materials and other items used for illegal production and operation; If the value of medical devices illegally produced and operated is less than 1000 yuan, a fine of more than 50,000 yuan 1500 yuan shall be imposed; If the value of the goods is more than 10000 yuan, a fine of more than 15 times and less than 30 times shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business, and the application for medical device license put forward by relevant responsible persons and units shall not be accepted within 10 years. The legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated of the income obtained during the illegal act of the unit, and a fine of more than 30% and less than 3 times of the income shall be imposed, and it is forbidden to engage in the production and operation of medical devices for life:
(3) engaging in the business activities of Class III medical devices without permission.