Medical device clinical trial management does not apply to these measures. Article 3 The National Health Commission is responsible for the supervision and management of the clinical use of medical devices.
Local health authorities at or above the county level are responsible for the supervision and management of the clinical use of medical devices in their administrative regions. Article 4 The main person in charge of medical institutions is the first person responsible for the management of the clinical use of medical devices in the organization.
Medical institutions should establish and improve the institution's clinical use of medical devices management system to ensure the rational use of medical devices. Article V above the county level local health authorities and medical institutions should be based on relevant state regulations to establish medical device emergency protection mechanism to protect the emergency treatment needs of emergencies. Article 6 The medical institutions shall implement the classification management of medical devices according to the medical device classification catalog issued by the state. Article 7 The competent department of health shall gradually improve the clinical use of artificial intelligence medical devices, and encourage medical institutions to strengthen the clinical use of artificial intelligence medical devices training. Chapter II Organization and Responsibilities Article 8 The National Health and Health Commission organizes 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 national clinical use of medical devices, studying key issues in the clinical use of medical devices, providing policy advice and recommendations, and guiding the rational use of medical devices.
Provincial health authorities to organize the establishment of provincial medical device clinical use of expert committees or commissioned by the relevant organizations, institutions responsible for the administrative region of the clinical use of medical devices, monitoring, evaluation and other work. Article IX above the second level of medical institutions should be set up to manage the clinical use of medical devices management committee; other medical institutions should be based on the actual situation of the organization, with the clinical use of medical devices responsible for the management of professional (part-time) staff.
Medical device clinical use management committee by the organization responsible for medical management, quality control, hospital infection management, medical engineering, information and other relevant functional department heads and related clinical, medical and technical departments responsible for guiding and supervising the clinical use of medical devices in the organization, the day-to-day management of relying on the relevant departments of the organization. Article X medical institutions clinical use of medical devices management committee and equipped with full-time (part-time) staff of the institution's clinical use of medical devices management to assume the following responsibilities:
(a) according to law to formulate the clinical use of medical devices and organize the implementation of the work system;
(b) the organization of the clinical use of medical devices, safety management, technical evaluation and demonstration;
(c) Monitor and evaluate the clinical use of medical devices, analyze, assess and feedback on the effectiveness of the use 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 use of clinical;
(d) monitoring and identifying the risk of safety in the clinical use of medical devices, analyzing and evaluating the safety events, and providing advice and guidance. Safety events, and provide advice and guidance;
(E) organization to carry out medical device management laws, rules, regulations and reasonable use of relevant systems, norms of business knowledge training, publicity and safety knowledge of the clinical use of medical devices. Article XI above the second level of medical institutions should be clear that the organization of the relevant functional departments and relevant departments of the clinical use of medical equipment management responsibilities; relevant functional departments, relevant departments should be designated to be responsible for the department or section of the clinical use of medical equipment management.
Other medical institutions should be based on the actual situation of the organization, clear relevant departments, departments and personnel responsibilities. Article XII above the second level of medical institutions should be equipped with its functions, tasks, scale of medical engineering and other professional and technical personnel, equipment and facilities. Article XIII of the medical equipment department is responsible for the daily management of medical equipment, medical equipment registration, regular verification, routine use of maintenance and repair work. Article XIV of medical institutions engaged in medical devices related to health professionals and technicians, should have the appropriate professional qualifications, health professional and technical qualifications or obtain the appropriate qualifications. Article XV of the medical institutions should be organized to carry out the clinical use of medical devices management of continuing education and training, to carry out the clinical use of medical devices, quality control, operating procedures, effect evaluation and other training. Article XVI of the medical institutions should strengthen the medical device information management, the establishment of medical devices and their use of information files. Article XVII of the medical institutions should be carried out annually to manage the clinical use of medical devices self-check, assessment, evaluation, to ensure that the clinical use of medical devices is safe and effective. Chapter III Clinical Use Management Article 18 The medical institutions shall establish the clinical use of medical devices, technical assessment and demonstration system and organization and implementation, to carry out technical needs analysis and cost-benefit assessment, to ensure that medical devices to meet clinical needs. Article XIX of the medical institutions to purchase medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system.
Medical institutions should properly save the purchase of Class III medical devices of the original information, and ensure that the information is traceable.