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<p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br /></p><p><br /></p><section class="" data-source="bj.96weixin.com" style="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="margin-right: auto; margin-left: auto; max-width: 100%; clear: both; width: 670px; overflow: hidden; box-sizing: border-box !important; word-wrap: break-word !important;"><section class="" style="max-width: 100%; box-sizing: border-box; border-left-width: 15px; border-left-style: solid; border-color: rgb(17, 159, 82) rgb(11, 181, 89) rgb(15, 191, 96); word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; line-height: 25px; word-wrap: break-word !important;"><section style="max-width: 100%; box-sizing: border-box; line-height: 1.4; word-wrap: break-word !important;"><section style="margin-top: 10px; max-width: 100%; box-sizing: border-box; color: inherit; float: left; word-wrap: break-word !important;"><section class="" style="padding-right: 5px; padding-left: 5px; max-width: 100%; display: inline-block; color: rgb(255, 255, 255); font-size: 14px; font-weight: bold; line-height: 32px; vertical-align: top; float: inherit; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(11, 181, 89);">导读</section><section class="" style="max-width: 100%; display: inline-block; vertical-align: top; border-left-width: 18px; border-left-style: solid; border-left-color: rgb(11, 181, 89); color: inherit; box-sizing: border-box !important; word-wrap: break-word !important; border-top-width: 15px !important; border-top-style: solid !important; border-top-color: transparent !important; border-bottom-width: 16px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section></section></section><section style="padding: 48px 20px 5px; max-width: 100%; box-sizing: border-box; font-size: 14px; 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-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;"> 目前，医疗器械行业正处于蓬勃发展期，并涉及到了多个行业，属于知识密集与资金密集型的高新技术产业。但是，大家是否注意到了在2015-2016年期间，医疗器械行业到底发生了哪些变化？</span></p></section></section></section></section></section><p><br /></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;"><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;"> 从2015-2016目前为止，纵观看来可以分为以下四点：</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;"><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;"> 1.医疗器械注册收费；</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;"><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;"> 2.医疗器械飞检 ；</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;"><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;"> 3.医疗器械临床试验 ；</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;"><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;"> 4.医械优先审批程序（征求意见稿）；</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;"><br /></span></p><p><br /></p><section class="" data-source="bj.96weixin.com" style="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 class="" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-top: 10px; margin-bottom: 10px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-bottom: -10px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="padding-right: 5px; padding-left: 5px; max-width: 100%; box-sizing: border-box; border-top-width: 2px; border-top-style: solid; border-bottom-width: 2px; border-bottom-style: solid; border-top-color: rgb(61, 167, 66); border-bottom-color: rgb(61, 167, 66); word-wrap: break-word !important; background-color: rgb(254, 255, 255);"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(255, 104, 39); box-sizing: border-box !important; word-wrap: break-word !important;">1、医疗器械注册收费</span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></section></section><section style="margin-top: -2px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 8px; border-top-style: solid; border-right-width: 8px; border-right-style: solid; border-top-color: rgb(61, 167, 66); border-right-color: rgb(61, 167, 66); word-wrap: break-word !important; border-left-width: 8px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 8px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section><section style="margin-top: -16px; margin-left: 4px; max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 6px; border-top-style: solid; border-top-color: rgb(255, 255, 255); border-right-width: 5px; border-right-style: solid; border-right-color: rgb(255, 255, 255); word-wrap: break-word !important; border-left-width: 5px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 6px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section></section></section></section></section></section></section><p><br /></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;"> 从<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><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;">11</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月起，福建省作为首个地方政府开始征收医疗器械注册费，江西、山东、内蒙古、海南、上海、北京等六省也相继将收费标准也公布了。医疗器械注册收费一方面可以使医疗器械生产企业在研发、生产环节等过程中加强生产质量管理，提升产品质量，保障产品的安全性和有效性，促进医疗器械产品注册工作顺利进行。另一方面也可以得出医疗器械行业越来越被重视。</span></span></p><p><br /></p><section class="" data-source="bj.96weixin.com" style="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 class="" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-top: 10px; margin-bottom: 10px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-bottom: -10px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="padding-right: 5px; padding-left: 5px; max-width: 100%; box-sizing: border-box; border-top-width: 2px; border-top-style: solid; border-bottom-width: 2px; border-bottom-style: solid; border-top-color: rgb(61, 167, 66); border-bottom-color: rgb(61, 167, 66); word-wrap: break-word !important; background-color: rgb(254, 255, 255);"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; color: rgb(255, 104, 39); box-sizing: border-box !important; word-wrap: break-word !important;">2、医疗器械飞检</span></section></section><section style="margin-top: -2px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 8px; border-top-style: solid; border-right-width: 8px; border-right-style: solid; border-top-color: rgb(61, 167, 66); border-right-color: rgb(61, 167, 66); word-wrap: break-word !important; border-left-width: 8px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 8px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section><section style="margin-top: -16px; margin-left: 4px; max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 6px; border-top-style: solid; border-top-color: rgb(255, 255, 255); border-right-width: 5px; border-right-style: solid; border-right-color: rgb(255, 255, 255); word-wrap: break-word !important; border-left-width: 5px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 6px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section></section></section></section></section></section></section><p><br /></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;"><br /></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;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvdDDJUcAPhc4UvCBddLyBSnXP5ZlAnfibWXtGxCLVcRiauDm3GQytZNkUviaWCrMSvW5PEib3nkoicuiaBg/0?wx_fmt=jpeg" data-ratio="0.6605166051660517" data-w="" /><br /></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;"><br /></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;"> 《药品医疗器械飞行检查办法》于<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><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;">5</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">18</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日经国家食品药品监督管理总局局务会议审议通过，自</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><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;">9</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日起施行。此后各省也积极地相应并颁布了医疗器械飞行检查办法。</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);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; 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;"> 从《办法》的实施开始，多地也频繁地展开了医疗器械飞检。从<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;">公布的通知来看，前后已有</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">28</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">家企业被飞检并公示。企业多存在人员培训、生产管理、质量控制、设计开发管理质量体系文件管控、不合格品控制等多方面不合格因素。</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);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; 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;"> 飞行检查具有不可预知性、独立性、高效性等特点，具备较大的威慑力。在构建“史上最严监管制度”的背景下，飞行检查对于药械监督检查必将发挥独特的作用，对企业的生产经营活动也将产生重大影响，必定会深度搅动行业生态。</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></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;"> 目前第二批国家级医疗器械检查员已结业，行业内将迎来新一轮的大飞检。</span></p><p><br /></p><section class="" data-source="bj.96weixin.com" style="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 class="" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-top: 10px; margin-bottom: 10px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-bottom: -10px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="padding-right: 5px; padding-left: 5px; max-width: 100%; box-sizing: border-box; border-top-width: 2px; border-top-style: solid; border-bottom-width: 2px; border-bottom-style: solid; border-top-color: rgb(61, 167, 66); border-bottom-color: rgb(61, 167, 66); word-wrap: break-word !important; background-color: rgb(254, 255, 255);"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(255, 104, 39); box-sizing: border-box !important; word-wrap: break-word !important;">3、医疗器械临床试验</span></section></section><section style="margin-top: -2px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 8px; border-top-style: solid; border-right-width: 8px; border-right-style: solid; border-top-color: rgb(61, 167, 66); border-right-color: rgb(61, 167, 66); word-wrap: break-word !important; border-left-width: 8px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 8px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section><section style="margin-top: -16px; margin-left: 4px; max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 6px; border-top-style: solid; border-top-color: rgb(255, 255, 255); border-right-width: 5px; border-right-style: solid; border-right-color: rgb(255, 255, 255); word-wrap: break-word !important; border-left-width: 5px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 6px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section></section></section></section></section></section></section><p><br /></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;"> 《医疗器械临床试验质量管理规范》自<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span><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;">6</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日起施行。新的医疗器械</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">GMP</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">是一份具有较强指导性和操作性的管理规范。随着《规范》正式出台，全国性的医疗器械临床试验自查和现场核查工作，也随之启动。</span></span></p><p><br /></p><section class="" data-source="bj.96weixin.com" style="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 class="" style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-top: 10px; margin-bottom: 10px; max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><section class="" style="margin-bottom: -10px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="padding-right: 5px; padding-left: 5px; max-width: 100%; box-sizing: border-box; border-top-width: 2px; border-top-style: solid; border-bottom-width: 2px; border-bottom-style: solid; border-top-color: rgb(61, 167, 66); border-bottom-color: rgb(61, 167, 66); word-wrap: break-word !important; background-color: rgb(254, 255, 255);"><section style="max-width: 100%; box-sizing: border-box; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 14px; font-family: 宋体; color: rgb(255, 104, 39); box-sizing: border-box !important; word-wrap: break-word !important;">4、医疗器械优先审批程序</span></section></section><section style="margin-top: -2px; max-width: 100%; box-sizing: border-box; display: inline-block; vertical-align: top; word-wrap: break-word !important;"><section class="" style="max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 8px; border-top-style: solid; border-right-width: 8px; border-right-style: solid; border-top-color: rgb(61, 167, 66); border-right-color: rgb(61, 167, 66); word-wrap: break-word !important; border-left-width: 8px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 8px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section><section style="margin-top: -16px; margin-left: 4px; max-width: 100%; box-sizing: border-box; width: 0px; border-top-width: 6px; border-top-style: solid; border-top-color: rgb(255, 255, 255); border-right-width: 5px; border-right-style: solid; border-right-color: rgb(255, 255, 255); word-wrap: break-word !important; border-left-width: 5px !important; border-left-style: solid !important; border-left-color: transparent !important; border-bottom-width: 6px !important; border-bottom-style: solid !important; border-bottom-color: transparent !important;"></section></section></section></section></section></section></section><p><br /></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;"> 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;">6</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">20</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日《医疗器械优先审批程序》（征求意见稿）出台了，其目的是为了保障医疗器械的临床使用需求，对符合下列条件之一的境内第三类和进口第二类、第三类医疗器械注册申请实施优先审批</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">:</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);"><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%; font-family: Calibri; 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; 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;"> （一）列入国家科技重大专项或国家重点研发计划的医疗器械。</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);"><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; 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;"> （二）符合以按要求的医疗器械：</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);"><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; 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;"> （三）其他应当优先审批的医疗器械。虽然只是征求意见稿，正式稿在不久后将出台。这个政策无疑给医械行业带来了新的血液和动力。</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);"><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 /></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);"><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;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvdDDJUcAPhc4UvCBddLyBSnCicNzsdtFe79KbsKJqakckC0OBS6DVURp1yibALs5Va4DE0JOfYIktGw/0?wx_fmt=jpeg" data-ratio="0.7416974169741697" data-w="" /><br /></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><br /></p><section class="" data-source="bj.96weixin.com" style="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="padding: 0.8em; max-width: 100%; border-width: 1px 0.4em; border-style: solid; border-color: rgb(61, 167, 66); border-radius: 0.3em; box-sizing: border-box !important; 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-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"> 中高端医疗器械是未来的一个发展趋势。<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><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;">12</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">16</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">,</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">世贸组织就扩大《信息技术协定》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(ITA)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">产品范围谈判达成全面协议</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">,</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">心脏起搏器、心电图记录设备、</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">X</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">射线断层扫描设备、核磁共振成像设备、超声扫描设备、眼科、外科、口腔科设备等</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">20</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">多种医疗器械设备和组件 计划于</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span><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</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日起实施降税</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">,</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">将为我国中高端医疗设备的出口创造更为有利的条件。</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2016</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年“十三五”实施，在制造业方面计划将着重布局在十大类高端装备制造。“高端装备创新工程”要求包括大型飞机、航空发动机及燃气轮机、智能绿色列车、节能与新能源汽车、、智能电网成套装备、高档数控机床、核电装备、高端诊疗设备等领域，实现自主研制及应用。其中就提到高端医疗设备。从一些迹象看来，中高端医疗器械会成为“新宠儿”。</span></span></p></section></section><p><br /></p><p><br /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; 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; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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 邮编：510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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 8764 5360 8764 2943 传真：020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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: 712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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: QQ: 712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; 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line-height: 24px; font-family: Arial, Verdana, sans-serif; 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><br /></p>
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发表于 2020-10-19 23:53:18