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The National Health Commission issued the “Work Procedures for the Evaluation of Clinical Applications of Medical Technologies.”
The National Health Commission issued the “Work Procedures for Assessing the Clinical Application of Medical Technologies,” which clarifies the medical technologies that have entered clinical application and defines the trigger conditions for evaluating them, organizational implementation, main contents, and the use of conclusions. First, regarding assessment trigger conditions, it clarifies that when medical technologies that have entered clinical application present relevant circumstances such as quality and safety risks, a clinical application assessment shall be initiated. Second, regarding assessment organizational implementation, it clarifies that the Medical Administration Center of the National Health Commission is responsible for organizing the assessment work, and that proactive monitoring of the clinical application status of medical technologies shall be strengthened, while relevant national-level quality control centers, national medical centers, and industry associations provide technical support. Third, regarding the main contents of the assessment, it organizes experts from relevant fields to conduct thorough argumentation on the safety, effectiveness, and ethical risks of the technology’s clinical application, forming an assessment conclusion and recommendations for clinical application management. Fourth, regarding the application of assessment conclusions, it clarifies that, based on the assessment conclusions, corresponding management measures will be taken for the clinical application of the related technologies. At the same time, the “Work Procedures” also clarify that health administrative departments at all localities should fulfill their regulatory responsibilities, strengthen the supervision of the clinical application of medical technologies in local medical institutions, and ensure risk is identified early and addressed with early interventions. (CCTV News)