Chapter I General Provisions
Article 1 In order to strengthen the safety management of the clinical use of medical devices, to reduce the risk of clinical use of medical devices, to improve the quality of medical care, and to protect the legitimate rights and interests of doctors and patients, this standard has been formulated based on the provisions of the "Practicing Physicians Law", the "Regulations on the Administration of Healthcare Institutions", "Regulations on Nurses", "Regulations on the Treatment of Medical Accidents The "Medical Device Supervision and Administration Regulations", "Hospital Infection Management Measures", "Disinfection Management Measures" and other provisions of the development of this specification.
Second, the clinical use of medical devices safety management, refers to medical institutions involved in medical services, medical device product safety, personnel, systems, technical specifications, facilities, environment and other safety management.
Article 3 The Ministry of Health is in charge of the national supervision of the safety of clinical use of medical devices, organizing the development of safety management standards for the clinical use of medical devices, according to the principles of medical device classification and risk grading to establish the safety control of clinical use of medical devices and monitoring and evaluation system, and organizing and carrying out the monitoring and evaluation of the clinical use of medical devices.
Article 4 The local health administrative departments at or above the county level are responsible for organizing and carrying out the safety supervision of the clinical use of medical devices in the administrative region according to the requirements of the Ministry of Health's relevant management standards and monitoring and evaluation system.
Article V medical institutions should be based on these norms to develop the clinical use of medical devices safety management system, establish and improve the organization of the clinical use of medical devices safety management system.
Two hospitals should be set up by the hospital leadership responsible for the clinical use of medical devices safety management committee, the committee consists of medical administration, clinical medicine and nursing, hospital infection management, medical device security management and other relevant personnel to guide the clinical safety management and monitoring of medical devices.
Chapter II Clinical Access and Evaluation Management
Article VI Clinical Access and Evaluation Management of Medical Devices refers to the management and technical measures taken by the medical institutions to ensure that the medical devices entered into clinical use are legal, safe and effective.
Article VII medical institutions shall establish a medical device procurement demonstration, technical evaluation and procurement management system to ensure that the procurement of medical devices in line with clinical needs.