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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (12): 1239-1239-1243.doi: 10.1009-0959.2026.010001

• 监管科学 •    下一篇

高质量立题依据在医疗器械审评的应用研究

仉琪   

  1. 国家药品监督管理局医疗器械技术审评中心，北京 100076
  • 收稿日期:2025-09-08 修回日期:2025-11-11 接受日期:2025-12-24 出版日期:2025-12-28 发布日期:2026-01-26
  • 基金资助:
    海南省博鳌乐城真实世界研究及医疗科技创新联合项目（ZDYF2024LCLH002）

Research on the Application of High-Quality Invention Basis in Medical Device Evaluation

ZHANG Qi   

  1. Center for Medical Device Evaluation， NMPA， Beijing 100076， China
  • Received:2025-09-08 Revised:2025-11-11 Accepted:2025-12-24 Online:2025-12-28 Published:2026-01-26

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摘要：

近年来，我国医疗器械的创新速度加快，迎来了蓬勃发展。医疗器械选题立题的质量，影响设计开发进程和注册申报效率，决定上市后的临床使用情况。本研究从医疗器械上市前审评视角，介绍立题依据的作用和意义，综述国际组织对药品、医疗器械立题依据的定位，梳理分析中国、美国、欧盟、日本医疗器械监管机构关于立题依据的注册申报要求。基于分析相关国家和地区在药品和医疗器械领域的研发指导政策，为鼓励更多以临床价值为导向、以患者为中心的创新医疗器械上市，本研究提出3方面的对策和建议：监管机构需要通过提出相关的注册申报资料要求，从下游发力引导上游注册申请人重视医疗器械立题质量；审评单位对具有颠覆性和迭代性创新技术的医疗器械，优化配置研审联动资源，采取事前事中服务，提高创新医疗器械审评的质量和效率；科研主管部门、审评单位、临床机构、科研机构协同推进监管科学研究，为创新技术尽早安全、有效地应用在医疗领域提供决策参考和能力储备。


关键词: 医疗器械, 立题依据, 设计开发, 注册申报

Abstract:

 In recent years， the innovation pace of medical devices in China has accelerated， ushering in a period of vigorous development. From the perspective of pre-market evalution of medical device， this article expounds on the role and significance of the basis for subject selection and invention， summarizes the positioning of the invention basis of pharmaceuticals and medical devices by international organizations， and sorts out and analyses the registration application requirements for the invention basis by medical device regulatory authorities in China， the United States， the European Union and Japan. To encourage more innovative medical devices oriented to clinical value and centered on patients to be marketed， this article puts forward countermeasures and suggestions from three aspects. Firstly， from the downstream， regulatory authorities need to guide upstream registration applicants to pay attention to the quality of medical device project initiation by establishing relevant requirements of registration application materials. Secondly， for medical devices with disruptive and iterative innovative technologies， the evaluation institutes should optimize the allocation of research and review linkage resources， provide pre-event and in-event services， and enhance the quality and efficiency of the evaluation of innovative medical devices. Thirdly， the competent authorities for scientific research， evaluation institutes， clinical institutions and research institutions should work together to promote regulatory science research， providing decision-making references and capacity reserves for the early， safe and effective approval of innovative technologies in the medical field.


Key words: Medical device； , Invention basis； , Design and development； , Registration applications

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