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2016年CFDA新规必知

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发表于 2020-10-19 23:46:18 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  2016<span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">7-9</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月间,</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">CFDA</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">密集发布了很多新的规定和征求意见稿,这些规定将影响到产品注册、临床和质量体系等诸多方面,了解和学习这些新要求才能跟上不断变化的监管要求。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(136, 136, 136); font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">  下面是小编汇总的信息。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p></p><section class="" data-author="易点微信编辑器" data-url="http://wxedit.yead.net" style="margin: 5px auto; max-width: 100%; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><section class="" style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important; background-image: url(&quot;http://mmbiz.qpic.cn/mmbiz_png/ianq03UUWGmLqGe7ZPniayvE4ibsX68xhzriaaVb9Fhv9QAQVDsgDlia0HCy4ZyjicD0IfZibvJQeQgtfPCKjprQic3ZEw/0?wx_fmt=png&quot;); background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: 0% 0%; background-repeat: no-repeat;"><h2 style="padding-top: 10px; max-width: 100%; color: rgb(0, 66, 118); box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">“</strong><strong style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械注册</strong><strong style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">”相关</strong></h2></section></section><section class="" data-author="易点微信编辑器" data-url="http://wxedit.yead.net" style="margin: 5px auto; max-width: 100%; color: rgb(62, 62, 62); line-height: 21.3333px; white-space: normal; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section style="margin-top: 10px; margin-bottom: 10px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; float: left; word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; width: 0.6em; height: 0.6em; border-radius: 100%; word-wrap: break-word !important; background-color: rgb(249, 110, 87);"></section><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_png/ianq03UUWGmIyxKD9AsYKVAlzQInSkLFE8n0xUhaItlFRfjueKzl2ZBMoDcwibW6iceClHHn2HSahCFrzFgECVH8Q/640?wx_fmt=png" data-type="png" data-w="50" style="margin-top: -0.8em; margin-left: 0.3em; box-sizing: border-box; vertical-align: middle; word-wrap: break-word !important; width: 1.5em !important; visibility: visible !important;" width="1.5em"></section><section style="max-width: 100%; box-sizing: border-box; float: right; word-wrap: break-word !important;"><section style="margin-left: -0.3em; max-width: 100%; box-sizing: border-box; float: right; width: 0.6em; height: 0.6em; border-radius: 100%; word-wrap: break-word !important; background-color: rgb(249, 110, 87);"></section><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_png/ianq03UUWGmIyxKD9AsYKVAlzQInSkLFEeib76e345VudOynTeyC5MywI0KygXicQId6CX4ibP6XCWezpGhmDws1Wg/640?wx_fmt=png" data-type="png" data-w="50" style="margin-top: 0.3em; box-sizing: border-box; vertical-align: middle; word-wrap: break-word !important; width: 1.5em !important; visibility: visible !important;" width="1.5em"></section><section style="max-width: 100%; box-sizing: border-box; clear: both; word-wrap: break-word !important;"></section></section><section style="margin-top: -20px; margin-bottom: 10px; padding: 10px 15px; max-width: 100%; box-sizing: border-box; width: 670px; display: inline-block; word-wrap: break-word !important;"><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">总局办公厅关于体外诊断试剂说明书文字性变更有关问题的通知</span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">食药监办械管〔2016〕<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">117</span>号 <span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span>年<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">8</span>月<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">5</span>日 发布</span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">关于对部分首次注册医疗器械申报资料加收一套纸质复印件及一套电子文件的公告(第</span>178<span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号) </span></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">2016年<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">9</span>月<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">20</span>日发布</span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">关于征求《体外诊断试剂注册管理办法》修正案意见的函</span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">食药监械管便函〔2016〕<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">62</span>号 <span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span>年<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">9</span>月<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">21</span>日发布</span></p></section><section style="margin-top: -25px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; float: left; word-wrap: break-word !important;"><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_png/ianq03UUWGmIyxKD9AsYKVAlzQInSkLFEnZChoOAHcgPVUggH72ed3pY1JobsiaXPE4liaQHx5xo2d73kSMuLHqPw/640?wx_fmt=png" data-type="png" data-w="50" style="margin-bottom: -0.46em; margin-left: 0.26em; box-sizing: border-box; vertical-align: middle; word-wrap: break-word !important; width: 1.5em !important; visibility: visible !important;" width="1.5em"><section style="max-width: 100%; box-sizing: border-box; width: 0.6em; height: 0.6em; border-radius: 100%; word-wrap: break-word !important; background-color: rgb(249, 110, 87);"></section></section><section style="max-width: 100%; box-sizing: border-box; float: right; word-wrap: break-word !important;"><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_png/ianq03UUWGmIyxKD9AsYKVAlzQInSkLFEheA3ZhAUHLDVXiajm1L2rkfJBBBDeK4qL4IlyjpSL8Laicnbriae0ibMFQ/640?wx_fmt=png" data-type="png" data-w="50" style="margin-right: 0.3em; box-sizing: border-box; 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font-size: 14px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">关于征求《钙磷</span>/<span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">硅类骨填充材料注册技术审查指导原则(征求意见稿)》意见的通知</span></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; 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font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">关于再次征求医疗器械生产质量管理规范附录定制式义齿及其现场检查指导原则意见的函</span></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">2016年<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">9</span>月<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span>日发布</span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">关于征求《医疗器械生产企业质量控制与成品放行指南(征求意见稿)》意见的函</span> </span></p><p style="max-width: 100%; min-height: 1em; line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(136, 136, 136); box-sizing: border-box !important; word-wrap: break-word !important;">食药监械监便函〔2016〕<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">127</span>号 &nbsp;<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span>年<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">9</span>月<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">21</span>日发布</span></p></section></section></section></section><p></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址:广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 &nbsp; &nbsp; &nbsp; 邮编:510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电话:(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;8764 2943 &nbsp; &nbsp; 传真:020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">全国统一免费服务热线:400-020-6788</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众帐号:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询:QQ: &nbsp;712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">设备咨询: &nbsp; QQ: &nbsp;712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">软件咨询:QQ: 712638 406</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">配件咨询:QQ: &nbsp; 712638 407</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">交流Q群:1106 11074</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">网址:http://www.yiliaoshebeiweixiu.com</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电子邮箱:service@yiliaoshebeiweixiu.com</span></p><p><span style="max-width: 100%; font-size: 14px; 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