美国医疗器械监管机构监管教育模式及对我国的启示
收稿日期: 2025-08-05
修回日期: 2025-10-10
录用日期: 2025-12-24
网络出版日期: 2026-01-26
基金资助
上海市2024年度“科技创新行动计划”软科学研究领域定向委托项目（项目编号：24692122800 ；项目名称：医疗器械注册审评新工具、新标准、新方法研究）
The Regulatory Education Framework of US Medical Device Regulatory Authorities and Implications for China
Received date: 2025-08-05
Revised date: 2025-10-10
Accepted date: 2025-12-24
Online published: 2026-01-26
目的：医疗器械监管机构面向被监管对象所开展的教育和培训活动（以下简称监管教育），例如线下培训、在线课程，能够帮助从业者获取法规知识，提升合规意识，有助于推进医疗器械产业高质量发展和高水平安全，是我国深化医疗器械监管改革的一项重要举措。本研究通过了解美国医疗器械监管机构面向从业者的监管教育模式，为我国医疗器械监管机构优化监管教育的形式与内容提供参考与借鉴。方法：采用案例分析法，通过公开信息研究分析美国医疗器械监管机构面向从业者提供的在线课程、培训会议、文字型引导信息等监管教育资源。结果与结论：美国食品药品管理局（Food and Drug Administration，FDA）医疗器械与放射健康中心（Center for Devices and Radiological Health，CDRH）基于监管流程、监管要求面向不同受众开展监管教育活动，通过静态文字信息、多媒体课程、在线研讨会议、线下互动会议等多样化形式，向从业者逐级递进地提供了覆盖流程入门、法规速查、系统培训、深度交流等多层次的教育资源，并以教育简报的形式整合为快速可及的资源清单。我国医疗器械监管机构可借鉴此类做法，结合我国产业实际情况，从顶层设计入手，持续完善监管教育体系与资源分配，提供具有实时性、实践性、互动性的优质监管教育资源。
关键词： 美国食品药品管理局（FDA）; 医疗器械与放射健康中心（CDRH）; 监管教育; 医疗器械; 产业培训
周世杰
,
庞博
,
耿瑛伦
,
李耀华
.
美国医疗器械监管机构监管教育模式及对我国的启示
Objective： The educational and training activities for regulated entities （hereinafter referred to as "regulatory education"）， such as in-person training and online courses， enable industry practitioners to acquire in-depth regulatory knowledge and strengthen their compliance awareness. This contributes to advancing the high-quality development and high-level safety of the medical device industry， serving as a critical initiative in China’s efforts to deepen medical device regulatory reform. This study examines the regulatory education framework implemented by US medical device regulatory authority for practitioners， aiming to provide references and insights for optimizing the form and content of regulatory education by Chinese medical device regulatory authorities.Methods： Case analysis approach was adopted， utilizing publicly available information to study regulatory education resources provided by US medical device regulatory agencies to practitioners， such as training courses， training conferences， and text-based guidance information.Results and Conclusion： Center for Devices and Radiological Health （CDRH） of US Food and Drug Administration （FDA） has implemented educational activities towards different audiences based on the regulatory process and regulatory requirements. Through diversified forms such as static text information， multimedia courses， online seminars， offline interactive meetings， CDRH has provided practitioners with multi-level educational resources covering process introduction， quick review of regulations， systematic training， and in-depth communication. These resources are integrated into a quick and accessible resource list in the form of Educational Newsletter. China's medical device regulatory authorities can draw on such practices， starting from top-level design， to improve the regulatory education system， optimize the allocation of educational resources， and provide high-quality regulatory educational resources that are timely， practical， and interactive to the medical device industry.
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