The paper discussed problems existing in the supervision system of medical devices adverse events in China. The paper proposed countermeasures and suggestions for the supervision of adverse events in the utilization of medical devices from the perspective of hospitals. By using the supervision theory for medical devices adverse events and combined with actual situation, the paper proposed the management lfow path and management system.%本文探讨了我国医疗器械不良事件监管工作存在的问题，并从医院的视角出发，提出我国医疗器械不良事件监管的对策建议。以医疗器械不良事件监管理论作为分析方法，结合目前医院医疗器械不良事件监管的实际情况，提出我国医疗器械不良事件监管工作的管理流程和管理体系。
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