Safety management system for clinical use of medical devices

Safety management standards for clinical use of medical devices (for Trial Implementation)

Chapter I General Principles

Article 1 In order to strengthen the safety management of clinical use of medical devices, reduce the risk of clinical use of medical devices, improve medical quality and protect the legitimate rights and interests of both doctors and patients, this specification is formulated in accordance with the Law on Medical Practitioners, Regulations on Management of Medical Institutions, Regulations on Nurses, Regulations on Handling Medical Accidents, Regulations on Supervision and Management of Medical Devices, Measures for Management of Hospital Infection and Measures for Management of Disinfection.

Article 2 The safety management of clinical use of medical devices refers to the safety management of medical device products, personnel, systems, technical specifications, facilities and environment involved in medical services of medical institutions.

Article 3 The Ministry of Health shall be in charge of the safety supervision of clinical use of medical devices nationwide, organize the formulation of safety management standards for clinical use of medical devices, establish a safety control and monitoring and evaluation system for clinical use of medical devices according to the principles of classification and risk grading of medical devices, and organize the monitoring and evaluation of clinical use of medical devices.

Fourth local health administrative departments at or above the county level shall be responsible for organizing the safety supervision of clinical use of medical devices within their respective administrative areas in accordance with the requirements of the relevant management norms and monitoring and evaluation system of the Ministry of Health.

Article 5 A medical institution shall formulate a safety management system for the clinical use of medical devices in accordance with this specification, and establish and improve the safety management system for the clinical use of medical devices in its own institution.

A safety management committee for clinical use of medical devices should be established in hospitals above the second level, and the hospital leaders should be responsible for it. The Committee is composed of medical administration, clinical medicine and nursing, hospital infection management, medical device safety management and other related personnel. To guide the clinical safety management and monitoring of medical devices.

Chapter II Clinical Access and Evaluation Management

Article 6 The management of clinical access and evaluation of medical devices refers to the management and technical measures taken by medical institutions to ensure the legality, safety and effectiveness of clinical use of medical devices.

Article 7 A medical institution shall establish a system of medical device procurement demonstration, technical evaluation and procurement management to ensure that the purchased medical devices meet the clinical needs.