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确保上市后医疗器械的安全性是各国监督管理部门应履行的职责。医疗器械在设计、功能方面的复杂性及风险特征决定了其监管方法的特异性。美国食品药品监督管理局下属的器械和放射健康中心(CDRH)负责医疗器械的上市前审批和上市后监管。相应地,CDRH通过上市前审批计划和上市后监测计划,使得医疗器械从设计、上市使用,到更新换代,组成了一个维护公众健康安全的统一体。本文为CDRH医疗器械上市后安全性监测计划的全部译文,包括CDRH上市后安全性监测框架及所包含的内容,以及用来监测和评估与使用医疗器械有关的不良事件和风险的方法,并提出持续性改进措施。希望能为加强我国医疗器械监管,建立规范化、系统化的监管模式提供借鉴。
To ensure the safety of medical devices after listing is the responsibility of supervisory and regulatory authorities in various countries. The complexity and risk characteristics of medical devices in their design and function determine the specificity of their regulatory approach. The Devices and Radiological Health Center (CDRH) of the U.S. Food and Drug Administration is responsible for premarket approval and post-marketing surveillance of medical devices. Accordingly, through the pre-IPO approval plan and the post-marketing monitoring plan, the CDRH has made medical devices from design, market use to replacement, and formed a unified body to safeguard public health and safety. This is the full translation of the post-marketing safety monitoring program for CDRH medical devices, including the post-marketing safety monitoring framework for CDRH and its contents, as well as methods for monitoring and assessing the adverse events and risks associated with the use of medical devices. Continuous improvement measures. Hoping to provide reference for strengthening the supervision of medical equipment in our country and establishing a standardized and systematic supervision mode.