血液透析装置上市后风险分析方法构建探讨  

Discussion on the Building of Post Market Risk Analysis Method in Hemodialysis Device

作　　者：徐红蕾[1] 彭晓龙[1] 田小俊[1] 王培连[1] 

机构地区：[1]国家食品药品监督管理局广州医疗器械质量监督检验中心,广州市510663

出　　处：《中国医疗器械杂志》2014年第5期371-374,共4页Chinese Journal of Medical Instrumentation

基　　金：广东省教育部科技部产学研结合项目(2011A091000038)

摘　　要：该文从政府监管的角度出发,探讨构建血液透析装置上市后风险分析方法。通过对国内血液透析装置使用现状提出可操作性的上市后风险识别和上市后风险估计研究方法,为监管部门开展血液透析装置风险管理工作提供技术指导,也为生产企业开展产品上市后风险评价提供参考。This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.

关 键 词：血液透析装置 上市后 风险分析 风险识别 风险估计 

分 类 号：R459.5[医药卫生—治疗学]