能力验证对医疗器械监管科学的价值作用研究
Regulatory Science for Proficiency Testing System of Medical Devices in China
容欧 1石志锋 2郝丽静3
作者信息
- 1. 华南理工大学医疗器械研究检验中心,广州 510006
- 2. 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
- 3. 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
- 折叠
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.
Abstract
Objective:To study the value mechanism of capability verification for medical devices regulatory science.Methods:Based on the development history of regulatory science,the development status and important enlightenment of China's medical device capability verification system construction were briefly described.Results and Conclusion:The construction of a capability verification system was an important means of quality control for medical device inspection and testing,which provided scientific technical and data support for its safety supervision and risk assessment.Based on the scientific perspective of medical device regulation,combined with the idea of promoting the integrated development of national quality infrastructure through capacity verification,the value and role of capacity verification impact mechanisms are proposed for reference by relevant institutions and industry personnel.
关键词
能力验证/监管科学/检验检测/作用机理/体系构建Key words
capability verification/regulatory science/inspection and testing/mechanism of action/system construction引用本文复制引用
基金项目
国家重点研发计划(2021YFC2400700)
广东省药品监督管理局科技创新项目(2021TDB24)
出版年
2024
NETL
NSTL
万方数据