These Measures are not applicable to the management of clinical trials of medical devices. Article 3 The National Health and Wellness Commission is responsible for the supervision and management of the clinical use of medical devices throughout the country.
The local health authorities at or above the county level shall be responsible for the supervision and management of the clinical use of medical devices within their respective administrative areas. Article 4 The main person in charge of a medical institution is the first person in charge of the clinical use management of medical devices in this institution.
Medical institutions should establish and improve the management system of clinical use of medical devices in their own institutions to ensure the rational use of medical devices. Fifth local health authorities and medical institutions at or above the county level shall, in accordance with the relevant provisions of the state, establish an emergency support mechanism for medical devices to ensure the emergency handling needs of emergencies. Article 6 Medical institutions shall carry out classified management of medical devices according to the classified catalogue of medical devices issued by the state. Seventh health authorities should gradually improve the clinical use level of artificial intelligence medical devices, and encourage medical institutions to strengthen the clinical use training of artificial intelligence medical devices. Chapter II Organization and Duties Article 8 The National Health and Wellness Commission shall organize the establishment of the National Expert Committee on Clinical Use of Medical Devices. The National Expert Committee on Clinical Use of Medical Devices is responsible for analyzing the clinical use of medical devices in China, studying the key problems in clinical use of medical devices, providing policy advice and suggestions, and guiding the rational use of medical devices in clinic.
The provincial health authorities shall organize the establishment of a provincial committee of experts on the clinical use of medical devices or entrust relevant organizations and institutions to be responsible for the monitoring and evaluation of the clinical use of medical devices within their respective administrative areas. Ninth medical institutions above the second level shall set up a management committee for the clinical use of medical devices; Other medical institutions should be equipped with full-time (part-time) staff to be responsible for the management of clinical use of medical devices according to their actual conditions.
The Management Committee for Clinical Use of Medical Devices is composed of the heads of relevant functional departments in charge of medical management, quality control, hospital infection management, medical engineering, information and other related departments, and is responsible for guiding and supervising the clinical use of medical devices in this institution, and relying on the relevant departments of this institution for daily management. Article 10 The management committee and full-time (part-time) staff of medical institutions shall bear the following responsibilities for the management of clinical use of medical devices in their own institutions:
(1) Formulating the working system for clinical use of medical devices according to law and organizing its implementation;
(2) Organizing the safety management, technical evaluation and demonstration of clinical use of medical devices;
(three) monitoring and evaluating the clinical use of medical devices, analyzing, evaluating and feeding back the use efficiency of medical devices in clinical departments; Supervise and guide the clinical use and safety management of high-risk medical devices; Put forward measures to intervene and improve the clinical use of medical devices, and guide the rational clinical use;
(four) monitoring and identifying the safety risks of clinical use of medical devices, analyzing and evaluating the use safety incidents, and providing advice and guidance;
(five) to organize and carry out the business knowledge training of laws, regulations and rules on the management of medical devices and the rational use of relevant systems and norms, and publicize the safety knowledge of clinical use of medical devices. Eleventh medical institutions above the second level shall clarify the management responsibilities of the relevant functional departments and departments of the institution for the clinical use of medical devices; Relevant functional departments and departments should designate special personnel to be responsible for the management of clinical use of medical devices in their own departments or undergraduate departments.
Other medical institutions should clarify the responsibilities of relevant departments, departments and personnel according to their actual conditions. Twelfth medical institutions above the second level should be equipped with medical engineering and other professional and technical personnel, equipment and facilities that are suitable for their functions, tasks and scale. Thirteenth medical device users are responsible for the daily management of medical devices, and do a good job in the registration, regular inspection, daily use and maintenance of medical devices. Fourteenth medical institutions engaged in medical equipment related work of health professional and technical personnel, should have the corresponding professional education, health professional and technical post qualifications or obtain the corresponding qualifications according to law. Fifteenth medical institutions should organize continuing education and training in the management of clinical use of medical devices, and carry out training in the scope of clinical use, quality control, operating procedures and effect evaluation of medical devices. Sixteenth medical institutions should strengthen the information management of medical devices and establish medical devices and their use information files. Seventeenth medical institutions should conduct self-examination, evaluation and evaluation on the management of clinical use of medical devices every year to ensure the safety and effectiveness of clinical use of medical devices. Chapter III Management of Clinical Use Article 18 Medical institutions shall establish a technical evaluation and demonstration system for clinical use of medical devices and organize their implementation, and carry out technical demand analysis and cost-benefit evaluation to ensure that medical devices meet clinical needs. Article 19 When purchasing medical devices, medical institutions shall examine the qualifications of suppliers and the certificates of medical devices, and establish a system of inspection records for incoming goods.
Medical institutions shall properly keep the original data of purchasing Class III medical devices to ensure the traceability of the information.