基于风险管理理念的植入性医疗器械结构化检查模型研究  

Research on a Structured Inspection Model for Implantable Medical Devices Based on Risk Management Concept

作　　者：崔佳 余洋 周明 龙翔 柳鹏程[2] CUI Jia;YU Yang;ZHOU Ming;LONG Xiang;LIU Peng-cheng(Center for Inspection of JSMPA;School of International Pharmaceutical Business,China Pharmaceutical University)

机构地区：[1]江苏省药品监督管理局审核查验中心 [2]中国药科大学国际医药商学院

出　　处：《中国食品药品监管》2025年第1期58-73,共16页China Food & Drug Administration Magazine

摘　　要：目的:基于风险管理理念开展植入性医疗器械的结构化检查模型研究,以期协助监管部门高效开展检查工作。方法:基于现有政策要求、江苏省实际情况及研究结果,利用专家访谈法确定植入性医疗器械质量风险因素指标,建立指标体系,利用层次分析法赋予各指标权重,量化指标并对风险进行分级,得出最终模型。结果:本文建立了包含4个一级指标、18个二级指标的量化评分体系,并赋予指标权重,构建了基于风险管理理念的植入性医疗器械结构化检查模型。结论:利用江苏省智慧监管数据库相关检查数据对植入性医疗器械的结构化检查模型进行验证,发现该模型适用于江苏省植入性医疗器械结构化检查,且可操作性和实用性均较强,能够为监管部门的检查工作提供参考。Objective:This articles explores a structured inspection model for implantable medical devices based on the concept of risk management,with the aim of assisting regulatory authorities in conducting inspections more efficiently.Methods:By considering existing policy requirements,the actual situation in J Province,and research results,expert interviews were conducted to identify quality risk factor indicators for implantable medical devices.An indicator system was established,with weights assigned to each indicator using the Analytic Hierarchy Process.Indicators were quantified,and risks were graded to develop the final model.Results:A quantitative scoring system was established,consisting of 4 primary indicators and 18 secondary indicators,with assigned weights for each indicator.A structured inspection model for implantable medical devices based on the risk management concepts was developed.Conclusion:Validation of the model using inspection data from J Province’s Smart Regulatory Database showed that the model is suitable for structured inspections of implantable medical devices in J Province.It demonstrates strong operability and practicality,providing useful references for regulatory authorities'inspection efforts.

关 键 词：风险管理 植入性医疗器械 结构化检查模型 权重分析 

分 类 号：R197[医药卫生—卫生事业管理]