Punishment without a medical device business license: those who practice without a medical device business license shall be ordered by the competent health department of the people's government at or above the county level to stop practicing, confiscate the illegal income and drugs and medical devices, and impose a fine of more than 5 times and less than 20 times the illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan. Anyone who, in violation of the provisions of this Law, forges, alters, buys, sells, rents or lends the Practice License of a Medical Institution shall be ordered by the competent health department of the people's government at or above the county level to make corrections, his illegal income shall be confiscated, and he shall be fined not less than five times but not more than fifteen times his illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan. If the circumstances are serious, the practice license of the medical institution shall be revoked. Two. Medical device agency requirements: 1. Requirements for operating medical devices: Application Form for License of Medical Device Operating Enterprise in quadruplicate, a copy of the applicant's qualification certificate, and a notice of pre-approval of the name of the medical device operating enterprise. 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. The warehouse requires that the non-residential living area should not be less than 20 square meters, and some products should be more than 100 square meters. It also requires facilities and equipment such as light, ventilation, dustproof, insect-proof, moisture-proof, rat-proof, pollution-proof, fire safety, detection and temperature and humidity adjustment, and lighting facilities to meet the requirements. Storage shall be managed by division and classification, clearly marked and stored according to product batches. The reservoir area should be divided into waiting area, qualified product area, delivery area, unqualified product area and other special places. 4. Requirements of health management system and after-sales service system: Enterprises engaged in medical devices should establish a sound health management system to ensure the safety of products. In addition, the enterprise should have the technical training and after-sales service ability suitable for the medical device products it operates or agree to provide technical support by a third party.
Legal basis: Article 99 of the Basic Medical Care and Health Promotion Law of People's Republic of China (PRC) violates the provisions of this law and practices without obtaining the practice license of a medical institution. The competent health department of the people's government at or above the county level shall order it to stop practicing, confiscate the illegal income, drugs and medical devices, and impose a fine of 5 times to 20 times the illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan. Anyone who, in violation of the provisions of this Law, forges, alters, buys, sells, rents or lends the Practice License of a Medical Institution shall be ordered by the competent health department of the people's government at or above the county level to make corrections, his illegal income shall be confiscated, and he shall be fined not less than five times but not more than fifteen times his illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan. If the circumstances are serious, the practice license of the medical institution shall be revoked.