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陕西省医疗器械质量监督检验院 >> 信息动态 >> 最新动态 >> 正文
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陕西省医疗器械质量监督检验院 >>最新动态 >> 正文
陕西省医疗器械质量监督检验院 圆满完成2019年国抽检验任务
陕西省医疗器械质量监督检验院 圆满完成2019年国抽检验任务
作者:未知 信息来源:本站原创 点击数:133 更新时间:2019/6/20 3:38:41

按照国家药品监督管理局的要求,2019年陕西省医疗器械质量监督检验院承担了立式蒸汽灭菌器、特定电磁波治疗器等8个品种183批次的国家医疗器械监督检验任务,随着最后一台检测设备数据的采集,我院国家医疗器械检验工作圆满落下帷幕。

为确保国家医疗器械监督检验任务保质保量按时完成,全院上下高度重视,及时召开专题会议研究部署。组织相关科室认真学习《2019年国家医疗器械年度计划抽检(中央补助地方项目)产品抽样方案》、《2019年国家医疗器械抽检产品检验方案》等文件,深入领会和贯彻抽验产品抽样方案和检验方案的内容。对本次监督检验任务所涉及到的仪器设备、耗材、试剂试药等方面进行充分的准备,积极与牵头单位沟通,进一步明确试验方法、检品用量、判定原则等要求。开检前开展扎实的模拟试验,确保人员、设备、样品、方法和环境设施等符合法定检验标准。

2019年4月初接收到首批样品起,为确保所收到的样品信息准确无误,业务科仔细对照收到的样品实物,认真核对国家抽验管理系统中的信息并及时录入。检验工作完成后,将严格按照《国家医疗器械抽查检验工作程序》要求,及时将检验报告书、国家医疗器械抽检结果通知书等资料寄送至中国食品药品检定研究院、抽样单位所在地及生产企业所在地监管部门,并将相关数据录入“国家医疗器械抽验信息系统”。

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