医疗器械定期风险评价报告的问题分析及对策  

The Analysis of Problems and Preliminary Exploration of Countermeasures in Periodic Risk Evaluation Report for Medical Devices

作　　者：杨建卫 赵祥宇 唐自逸 刘长青 Yang Jianwei;Zhao Xiangyu;Tang Ziyi;Liu Changqing(The Shandong Adverse Drug Reaction Monitoring Center,Jinan Shandong 250014,China;Linyi Drug Alert Center,Linyi Shandong 276002,China)

机构地区：[1]山东省药品不良反应监测中心,山东济南250014 [2]临沂市药物警戒中心,山东临沂276002

出　　处：《医疗装备》2024年第4期35-37,45,共4页Medical Equipment

基　　金：山东省医疗器械不良事件专业评价项目(2023-SDADR-005)。

摘　　要：医疗器械定期风险评价报告(PRER)对产品上市后的安全性研究具有重要意义。该研究通过梳理、汇总国家医疗器械不良事件监测信息系统内山东省注册人提交的PRER,结合基层调研和工作开展的实际情况归纳PRER存在的问题,探讨加强医疗器械定期风险评价工作的创新举措,确保企业主体责任落实到位。The Periodic Risk Assessment Report(PRER)for medical devices is of great significance for the safety research of products after the products launch.In this study,by sorting and summarizing the PRERs submitted by registered individuals in Shandong Province within the National Medical Device Adverse Event Monitoring Information System,and combining with grassroots research and actual work,the existing problems of PRERs were summarized,and innovative measures to strengthen regular risk assessment of medical devices were explored to ensure the implementation of corporate main responsibilities.

关 键 词：定期风险评价报告 医疗器械不良事件监测 风险控制 对策 

分 类 号：R197.39[医药卫生—卫生事业管理]