| 能力验证对医疗器械监管科学的价值作用研究 |
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| 引用本文： | 容欧,石志锋,郝丽静. 能力验证对医疗器械监管科学的价值作用研究[J]. 中国药事, 2024, 38(3): 307-311 |
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| 作者姓名： | 容欧 石志锋 郝丽静 |
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| 作者单位： | 华南理工大学医疗器械研究检验中心，广州 510006;华南理工大学医疗器械研究检验中心，广州 510006 ；华南理工大学国家药品监督管理局医疗器械监管科学研究基地，广州 510006 |
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| 基金项目： | 国家重点研发计划项目（编号 2021YFC2400700）；广东省药品监督管理局科技创新项目（编号 2021TDB24） |
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| 摘 要： | 目的：研究能力验证对医疗器械监管科学的价值作用。方法：结合监管科学发展历程，简述了我国医疗器械能力验证体系建设的发展现状和重要启示。结果与结论：能力验证体系建设是医疗器械检验检测质量控制的重要手段，为其安全监管和风险评估提供了科学的技术支撑和数据支持。基于医疗器械监管科学视角，结合能力验证促进国家质量基础设施融合发展思路，提出能力验证影响机制的价值作用政策建议，供相关机构和行业人员参考使用。
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| 关 键 词： | 能力验证；监管科学；检验检测；作用机理；体系构建 |
| 收稿时间： | 2023-01-29 |
Regulatory Science for Profi ciency Testing System of Medical Devices in China |
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| Rong Ou,Shi Zhifeng,Hao Lijing. Regulatory Science for Profi ciency Testing System of Medical Devices in China[J]. Chinese Pharmaceutical Affairs, 2024, 38(3): 307-311 |
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| Authors: | Rong Ou Shi Zhifeng Hao Lijing |
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| Affiliation: | Medical Devices Research and Testing Center, South China Universityof Technology, Guangzhou 510006 , China;Medical Devices Research and Testing Center, South China Universityof Technology, Guangzhou 510006 , China ；NMPA Research Base of Regulatory Science for Medical Devices,South China University of Technology, Guangzhou 510006 , China |
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| Abstract: | Objective: To study the value mechanism of capability verifi cation for medical devices regulatoryscience. Methods: Based on the development history of regulatory science, the development status and importantenlightenment of China''s medical device capability verification system construction were briefly described.Results and Conclusion: The construction of a capability verifi cation system was an important means of qualitycontrol for medical device inspection and testing, which provided scientifi c technical and data support for its safetysupervision and risk assessment. Based on the scientifi c perspective of medical device regulation, combined withthe idea of promoting the integrated development of national quality infrastructure through capacity verifi cation,the value and role of capacity verifi cation impact mechanisms are proposed for reference by relevant institutionsand industry personnel. |
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| Keywords: | capability verification； regulatory science； inspection and testing； mechanism of action； systemconstruction |
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