医疗器械注册与</span> <span class="text-source-left01">|</span> <span class="detail_head_title aut_txt_span"><span class="aut_txt">作者:</span>pmtb10982</span> <span class="text-source-left01">|</span> <span class="detail_head_title pub_txt_span"><span class="pub_txt">发布时间: </span>193天前</span> <span class="text-source-left01">|</span> <span class="detail_head_title times_txt_span">697 <span class="times_txt">次浏览</span></span> <style> .wp-article_detail_content .bdsharebuttonbox a{ margin:3px;} .wp-article_detail_content .editshaimg{ margin:3px;} .bdsharebuttonbox.bshare-custom a.wpshare-sinaminiblog { background: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_tsinaa.png");} .bdsharebuttonbox.bshare-custom a.wpshare-sinaminiblog:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_tsina.png");} .bdsharebuttonbox.bshare-custom a.bshare-qqim { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_sqqa.png");} .bdsharebuttonbox.bshare-custom a.bshare-qqim:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_sqq.png");} .bdsharebuttonbox.bshare-custom a.bshare-weixin { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_weixina.png");} .bdsharebuttonbox.bshare-custom a.bshare-weixin:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_weixin.png");} .bdsharebuttonbox.bshare-custom a.wpshare-twitter { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_twittera.png");} .bdsharebuttonbox.bshare-custom a.wpshare-twitter:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_twitter.png");} .bdsharebuttonbox.bshare-custom a.wpshare-facebook { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_facebooka.png");} .bdsharebuttonbox.bshare-custom a.wpshare-facebook:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_facebook.png");} .bdsharebuttonbox a.bds_tqq_a { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_tqqa.png");} .bdsharebuttonbox a.bds_tqq_a:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_tqq.png");} .bdsharebuttonbox.bshare-custom a.wpshare-qzone { background: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_qzonea.png");} .bdsharebuttonbox.bshare-custom a.wpshare-qzone:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_qzone.png");} .bdsharebuttonbox a.bds_bdhome_a { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_bdhomea.png");} .bdsharebuttonbox a.bds_bdhome_a:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_bdhome.png");} .bdsharebuttonbox.bshare-custom a.bshare-douban { background: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_doubana.png");} .bdsharebuttonbox.bshare-custom a.bshare-douban:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_douban.png");} .bdsharebuttonbox a.bds_kaixin001_a { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_kaixin001a.png");} .bdsharebuttonbox a.bds_kaixin001_a:hover { background-image: url("http://static.websiteonline.cn/website/plugin/article_detail/view/images/sha_kaixin001.png");} .wp-article_detail_content .bdsharebuttonbox img{float:left;} .shareshow a{display: block;height:16px;padding-left:17px; width:auto;background-repeat: no-repeat;float:left;} </style> <span class="text-source-left01 shareshow">|</span> <span class="detail_head_title shareshow">分享到: </span> <div class="bdsharebuttonbox shareshow bshare-custom"> </div> </div> </div> <div class="artview_intro" style="display:block;font-family:SimSun;font-size:12px;color:#868686;font-weight:normal;text-decoration:none;line-height:12px;background:#F5F5F5;border-style:solid solid solid solid;border-color:#E5E5E5 #E5E5E5 #E5E5E5 #E5E5E5;border-width:1px 1px 1px 1px;"> </div> <div class="artview_content" style="display:block;font-family:SimSun;font-size:12px;color:#5A5A5A;font-weight:normal;text-decoration:none;"> <div class="artview_detail" setsid="article136"> <section data-tools="135编辑器" data-id="110189" style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"><section style="margin: 10px auto; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"><section style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; display: flex; justify-content: center; visibility: visible;"><section style="margin: 0px; padding: 2px 0px; outline: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important; font-size: 14px; color: rgb(163, 198, 58); text-align: center; border-bottom: 1px solid rgb(250, 171, 19); visibility: visible;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px; font-family: 微软雅黑, "Microsoft YaHei"; visibility: visible;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;">变更注册管理</strong></span></section></section></section></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; visibility: visible; box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-family: 微软雅黑, "Microsoft YaHei"; visibility: visible;">我国对于第二类、第三类医疗器械施行注册制度，产品注册证有效期是五年，在产品有效期内进行相关的变更是很常见的，<span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(141, 179, 226); visibility: visible;">如产品改进的变更，标准修订引起的变更，客户提出的变更需求等等</span>，对于这些变更，应按照质量管理体系的要求进行全面的<span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(118, 146, 60); visibility: visible;">识别、评审、判断以及实施</span>，接下来小编带大家看下变更注册的要求。</span><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; caret-color: red; font-family: 微软雅黑, "Microsoft YaHei"; visibility: visible;"> </span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; visibility: visible; box-sizing: border-box !important;"><br style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"/></p><p><section data-role="list" style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; visibility: visible; box-sizing: border-box !important;"><strong style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; visibility: visible;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-family: 微软雅黑, "Microsoft YaHei"; visibility: visible;">1.<span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; line-height: normal; visibility: visible;"> </span>变更注册的条件：</span></strong><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-family: 微软雅黑, "Microsoft YaHei"; visibility: visible;">已注册的第二类、第三类医疗器械产品，其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化，有可能影响该医疗器械安全、有效的；发生其他变更，需进行、规格、结构及组成、适用范围、产品技术要求、进口医疗器械的生产地址等，发生变更的，属于实质性变化</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; outline: 0px; max-width: 100%; clear: both; min-height: 1em; visibility: visible; box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-family: 微软雅黑, "Microsoft YaHei"; color: rgb(214, 168, 65); visibility: visible;">2）办理 </span></span></p><p style="color: rgb(90, 90, 90); font-family: Arial, 宋体, Helvetica, sans-serif, Verdana; font-size: 12px;"><span style="color: rgb(255, 255, 255); line-height: 241%; font-family: KaiTi_GB2312; font-size: 16px;">Copyright ? 2009-2011,www.singae.com,All rights reserved 陕ICP备18015806号</span></p><p style="color: rgb(90, 90, 90); font-family: Arial, 宋体, Helvetica, sans-serif, Verdana; font-size: 12px;"><span style="color: rgb(255, 255, 255); font-family: KaiTi_GB2312; font-size: 16px;">主营业务：医疗器械检验仪器、医用内窥镜光学性能检测仪、工装夹具、仪器仪表、试验机</span></p><p style="color: rgb(90, 90, 90); font-family: Arial, 宋体, Helvetica, sans-serif, Verdana; font-size: 12px;"></p></div> </div><script> $('#layerC9C0B9C0E60EA7CAFE1BBE8F9EE50D14').triggerHandler('layer_ready');</script><div id='layer0DB65D6267C04F17A7684BE66C674974' type='media' inbuttom='1' class='cstlayer' style='left: 834px; 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