Individuals purchasing their own medical equipment behavior does not apply to these measures. Article 3 The municipal market supervision and management department is responsible for the supervision and management of the operation of medical devices and the use of medical equipment quality and safety supervision and management within the administrative region of the city, to guide and supervise the supervision and management of the district market supervision and management department to carry out supervision and management work, and the organization and implementation of these measures.
District market supervision and management department is responsible for the supervision and management of medical device business within the jurisdiction and the use of medical device quality and safety supervision and management.
Health administrative departments are responsible for the supervision and management of the use of medical devices in medical institutions, disease prevention and control institutions, family planning technical service institutions, blood stations, single plasma stations and other medical device use units within the scope of statutory duties.
Civil affairs, business and other relevant administrative departments within their respective statutory duties to assist in the implementation of these measures. Article IV of medical equipment business enterprises and the use of units should ensure that the operation and use of medical equipment is safe and effective. Medical device business enterprises and the use of units of legal representatives, the relevant person in charge shall ensure that the business enterprises, the use of units in accordance with laws and regulations require the operation and use of medical devices.
Medical equipment market operators, business managers should be admitted to the business operators to carry out strict management, and urge their legitimate business. Article V medical device business enterprises, the use of units should be organized to direct contact with medical equipment personnel to accept pre-employment and annual health checks, the establishment of health records. Suffer from diseases that may contaminate medical devices, shall not be engaged in direct contact with medical devices, once found shall be immediately transferred from the post.
Medical device business enterprises, the use of units should develop annual training programs, on-the-job personnel to carry out pre-job training and continuing training, the establishment of training records. Training content should include medical device laws and regulations, professional knowledge and skills, quality management system, responsibilities and job procedures. Article VI of medical devices business enterprises, the use of units to purchase medical devices should fulfill the following obligations, and retain the relevant supporting materials:
(a) to determine the legal qualifications of the supply unit;
(b) to determine the legal identity of the sales staff of the supply unit;
(c) to check the purchase of medical devices, the certificate of registration or filing credentials;
(d) Request for legal bills issued by the supplier unit;
(e) signed with the supplier unit including quality responsibility and after-sales service responsibility content of the agreement;
(f) the medical device qualification documents. Chapter II of the medical device business management Article 7 engaged in the third class of medical devices business enterprises should have to meet the requirements of quality management of medical equipment business information management system to ensure that the operation of the product can be traced.
For other medical device production and management enterprises to provide storage, distribution services of medical devices business enterprises should have with the commission to carry out real-time electronic data exchange and the realization of the whole process of product management can be traced back to the information management platform and technical means. Article 8 Any unit or individual operating non-medical device products, its labeling, instructions shall not be marked with the same or similar to the intended purpose of the medical device has been classified and defined. Article IX medical device business enterprises operating non-medical device products, should be displayed separately, there is a clear separation, and set up a clear distinction labeling.
Medical device sales staff shall not confuse medical devices and non-medical products, sales of non-medical products should take the initiative to inform the consumer of its purchase of non-medical products. Article 10 in the form of lectures, on-site experience to consumers to promote medical devices or the intended purpose of the same, similar to the medical device products, the activity organizer should be 7 days in advance to the activities of the market supervision and management of the district where the activity time, location and other information. Activity organizers should also submit the relevant qualifications of enterprises and products.
Received the report of the District Market Supervision and Administration Department shall verify the relevant information, if necessary, to the activities of the site for supervision and inspection, and found that violations of law should be investigated and dealt with in a timely manner. Article XI of medical equipment fairs, expositions, trade fairs and other activities organized by the unit shall strictly audit the admission of production and operation of licensing, medical device registration or filing certificates, etc., to ensure that the admission of enterprises, product legality, and 10 days in advance to inform the activities of the market supervision and management of the district in which the activities of the market supervision and management department in writing.
Site display is still in the research and development stage of medical devices, the admission of enterprises should be clearly labeled. Article XII of the centralized trading market of medical devices operators, business managers should develop business tenants to enter the audit system, strengthen the management of the entry business tenants, regular business tenants to carry out regulatory laws and regulations of medical equipment publicity, and the business tenants to check the business situation.
Operators, business managers found that the business operators have illegal behavior, should be stopped in a timely manner, and within two working days to the market supervision and management departments in the district report.
Operators, business managers should be December 31 each year to the district market supervision and management departments to submit an annual report on market management.