Management Measures for the Clinical Application of Medical Technologies

1. Core Concepts and Definitions

   • Firstly, "medical technology" is defined as the professional medical methods and measures adopted by medical institutions and their medical personnel for the purpose of diagnosing and treating diseases, making judgments about diseases, eliminating diseases, alleviating conditions, relieving pain, improving functions, prolonging life, and helping patients recover their health.
   • "Clinical application" specifically refers to the entire process of applying the aforementioned medical technologies to the human body.
   • Therefore, the core of the Management Measures for the Clinical Application of Medical Technologies is a normative document formulated by the state to strengthen the management of the clinical application of medical technologies, ensure medical quality and patient safety, covering a series of activities such as the classification, access, application, evaluation, and supervision of medical technologies. It is the fundamental rule governing "whether a medical technology should be used, who should use it, and how it should be used."

2. Categorized Management of Medical Technologies (Classification System)

   • Based on technical difficulty, risk level, and ethical impact, these Measures implement categorized and hierarchical management of medical technologies. This is the foundation of management. They are mainly divided into three categories:
     • Prohibited Technologies: Technologies that are explicitly prohibited from clinical application due to uncertain safety and efficacy, or significant ethical issues. For example, certain treatment methods that have been completely phased out or proven harmful by the scientific community.
     • Restricted Technologies: Technologies with confirmed safety and efficacy, but which involve high technical difficulty and risk, impose special requirements on the service capacity and personnel level of medical institutions, and require strictly controlled management processes. For example: organ transplantation technology, cardiovascular interventional technology, tumor ablation therapy technology, etc. Such technologies require registration and filing.
     • General Technologies: Technologies with confirmed safety and efficacy, relatively low technical difficulty and risk, and widespread adoption. For example: conventional appendectomy, ordinary internal fixation for fractures, etc. These technologies are managed by medical institutions themselves, with a focus on ensuring their standardized implementation.

3. Key Management Links and Processes

   • Institution and Personnel Qualifications: To carry out restricted technologies, medical institutions must meet specific basic conditions such as equipment, facilities, professional teams, and technical capabilities, and file or apply for registration with the health administrative department. Medical personnel must also undergo standardized training and pass assessments.
   • Technology Assessment and Ethical Review: For new technologies or technologies introduced that have not been locally applied before, medical institutions need to organize technology assessments and ethical reviews to ensure their scientificity and ethical compliance. Restricted technologies especially require strict ethical review.
   • Informed Consent: For restricted technologies or technologies with relatively high risks, medical institutions must fulfill more detailed informed notification obligations and obtain written consent from the patient or their family members. This is central to protecting patient autonomy.
   • Quality Control and Information Reporting: Medical institutions need to establish an internal quality management and control system for the clinical application of medical technologies to monitor the application process and quality of the technologies. At the same time, they must report information such as the implementation of restricted technologies and adverse events to the National Management Information System for Clinical Application of Medical Technologies as required.
   • Dynamic Evaluation and Exit: Health administrative departments will regularly organize evaluations of the clinical application of medical technologies, especially restricted technologies. For technologies found to have serious safety issues or no longer meeting application conditions, adjustments (e.g., from restricted to prohibited) or termination of their clinical application will be implemented.

4. Regulatory Bodies and Legal Responsibilities

   • Regulatory System: The National Health Commission is responsible for the supervision and management of the clinical application of medical technologies nationwide. Local health administrative departments at or above the county level are responsible for the daily supervision and management of the clinical application of medical technologies within their respective administrative regions.
   • Consequences of Violations: If a medical institution carries out restricted technologies without filing, uses medical personnel who have not undergone standardized training, or violates technical management regulations causing serious consequences, it will face administrative penalties such as warnings, fines, orders to suspend practice, or even revocation of the Medical Institution Practice License. Responsible personnel will also be dealt with according to the law.

5. Summary of Core Objectives and Significance

   • Ultimately, these Measures aim to establish a closed-loop management system covering the entire lifecycle of medical technologies, encompassing "pre-application access, in-process supervision, and post-application evaluation." Their fundamental goal is to maximize the prevention of technological risks through strict regulations while encouraging innovation and development in medical technology, ensuring that any technology applied to patients is safe, effective, and ethical, thereby fundamentally safeguarding patients' health rights and medical safety.