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<p><br /><img data-type="gif" class="__bg_gif " data-ratio="0.10555555555555556" data-w="720" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/640?wx_fmt=gif" style="white-space: normal;font-size: 15px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p><span style="font-size: 15px;">来源:股城网</span></p><p style="font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><br /></p><p style="font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">据国家药监局8月1日消息，为深入贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号）精神，加快推进医疗器械产业创新发展，在前期上海、广东、天津自贸区开展医疗器械注册人制度试点工作的基础上。</span></p><p><br /></p><p><img class="large" data-ratio="0.6671875" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhveCFJZzL5dszjd4FiaMzvCMQkeHK6D6yvKJ9luaHAD4gEuKEx3m3CicndXkQBzicic4dEGhXmX3Echdqw/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="border-width: 0px;border-style: initial;border-color: initial;width: 600px;display: block;" /></p><p style="margin-top: 26px;font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">医疗器械产业今日，国家药品监督管理局（以下简称国家局）发布《关于扩大医疗器械注册人制度试点工作的通知》（国药监械注〔2019〕33号，以下简称《通知》），进一步扩大医疗器械注册人制度试点，为全面实施医疗器械注册人制度进一步积累经验。</span></p><p style="margin-top: 22px;font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">《通知》明确，北京、天津、河北、辽宁、黑龙江、上海、江苏、浙江、安徽、福建、山东、河南、湖北、湖南、广东、广西、海南、重庆、四川、云南、陕西等21个省、自治区、直辖市参加本次医疗器械注册人制度试点。</span></p><p style="margin-top: 22px;font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">《通知》对参与试点工作的注册人和受托生产企业分别规定了相应的条件和义务责任，明确双方应当签订委托合同和质量协议，并对产品注册、变更和生产企业许可证办理程序进行了规定。</span></p><p style="margin-top: 22px;font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">同时强调各级药品监管部门应当加强对注册人履行保证医疗器械质量、上市销售与服务、医疗器械不良事件监测与评价、医疗器械召回等义务情况的监督管理。对委托生产涉及跨区域的，相关省级药品监管部门要在协调一致的基础上，确定跨区域监管各方职责划分，落实日常监管责任主体，确保对医疗器械全生命周期全链条监管无缝隙无死角。</span></p><p style="margin-top: 22px;font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 14px;">国家局扩大医疗器械注册人制度试点工作，其目的在于进一步探索建立医疗器械注册人制度以及委托生产管理制度，优化资源配置，落实主体责任；探索建立完善的注册人医疗器械质量管理体系，明确医疗器械注册人、受托人等主体之间的法律关系，在责任清晰、风险可控的基础上，构建注册人全生命周期质量管理制度和体系；探索创新医疗器械监管方式，有效落实“监管工作一定要跟上”的要求，进一步释放产业活力，推动医疗器械产业高质量发展，满足人民群众使用高水平医疗器械需求。</span><span class="bjh-p"></span></p><p><span style="font-size: 15px;"><br /></span><br /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;">赞<span style="max-width: 100%;line-height: 25px;box-sizing: border-box !important;word-wrap: break-word !important;">是一种友谊 | </span><span style="max-width: 100%;line-height: 25px;color: rgb(192, 0, 0);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;">分享</strong></span><span style="max-width: 100%;line-height: 25px;box-sizing: border-box !important;word-wrap: break-word !important;">传递智慧</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);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;" /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 0.5px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 1px;line-height: 25.6px;white-space: pre;color: rgb(68, 68, 68);font-family: 宋体;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 style="max-width: 100%;color: rgb(95, 73, 122);font-size: 14px;line-height: 24.381px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 18px;color: rgb(62, 62, 62);line-height: 25px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;white-space: normal;font-family: 微软雅黑;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;">，您身边专业超声维修专家</strong></span></strong></strong></strong></span></strong></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 0.5px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 1px;line-height: 25.6px;white-space: pre;color: rgb(68, 68, 68);font-family: 宋体;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 style="max-width: 100%;color: rgb(95, 73, 122);font-size: 14px;line-height: 24.381px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 18px;color: rgb(62, 62, 62);line-height: 25px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;white-space: normal;font-family: 微软雅黑;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(62, 62, 62);font-size: 15px;line-height: 24px;box-sizing: border-box !important;word-wrap: break-word !important;">超声一站式服务商</span></strong></span></strong></strong></strong></span></strong></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);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;" /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;font-family: 微软雅黑;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;text-indent: 0em;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;">地址：广州市天河区高塘路235号时代E-PARK7栋801、802室 </span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;">邮编：510507</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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 </span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">传真：020-8722 8623</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;">公司官网：http://gb.parts-ultrasound.com/</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;font-family: 微软雅黑;line-height: 24.381px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;text-indent: 0em;font-size: 14px;font-family: Arial, Verdana, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">微信公众帐号：</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", " ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);text-align: left;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="rich_pages " data-ratio="1" data-s="300,640" data-type="png" data-w="344" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcvQ5W66skZY3mYSqpoRYIMn3LOS0l9GkWVqSdiaw2RiclU8MiatfDmia3YvXxPRgDFiaZFibgUOEEfaYhA/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;width: 344px !important;visibility: visible !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;font-family: 微软雅黑;line-height: 24.381px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址：https://renchengyiliao.1688.com</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">电子邮箱：sales@parts-ultrasound.com</span></p><p><br /></p>
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发表于 2020-10-19 22:44:54