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<p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: left; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">内容转自公众号：<a class="rich_media_meta rich_media_meta_link rich_media_meta_nickname" style="margin-right: 8px; margin-bottom: 10px; display: none; vertical-align: middle; max-width: none; line-height: 20px; white-space: normal; background-color: rgb(255, 255, 255);"></a><a class="rich_media_meta rich_media_meta_link rich_media_meta_nickname" style="margin-right: 8px; margin-bottom: 10px; display: none; vertical-align: middle; max-width: none; line-height: 20px; white-space: normal; background-color: rgb(255, 255, 255);"></a><a class="rich_media_meta rich_media_meta_link rich_media_meta_nickname" style="margin-right: 8px; margin-bottom: 10px; display: none; vertical-align: middle; max-width: none; line-height: 20px; white-space: normal; background-color: rgb(255, 255, 255);"></a><strong><span style="color: rgb(62, 62, 62); line-height: 19.2px; white-space: pre-wrap; font-size: 16px; background-color: rgb(255, 255, 255);">奥咨达（<span style="color: rgb(173, 173, 173); font-size: 14px; line-height: 20px; background-color: rgb(255, 255, 255);">medicaldeviceCRO</span>）</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-w="540" data-ratio="0.35" data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/2OZNJAdjibAwbLVcxnwZP4zBwdhXVCIgc5B7TGdv6QEaicbkNy8xkMqxG4qeL1MSr5MCJAZ9yJQcIv0KysRreyyg/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); line-height: 25.6px; text-align: center; 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 style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;">关于征求《北京市进口医疗器械代理人管理办法意见》的通知<br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></span></p><hr style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);" /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: right; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">发布时间：2016-06-16<br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></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);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></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);">各区食品药品监督管理局、各直属分局、各有关单位：<br 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;" /> 为贯彻落实《医疗器械监督管理条例》及配套法规中有关注册代理人的要求，规范注册代理人行为，我局组织制定了《北京市进口医疗器械代理人管理办法》，现公开征求意见。请各单位将意见报送我局医疗器械注册和监管处，其他单位和个人的意见可通过电子邮件或传真反馈。意见反馈时间截止至2016年6月25日。<br 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;" /> 传真：010-83560730<br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /> 邮件：qixiechu@bjda.gov.cn。（请在邮件主题处注明“注册代理人管理办法反馈意见”）</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);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" />附件：</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);">北京市进口医疗器械代理人管理办法（征求意见稿）</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: right; 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;" />北京市食品药品监督管理局<br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" />2016年6月13日</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: right; 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 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%; color: rgb(2, 30, 170); 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;">附件：<br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: right; 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 style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); box-sizing: border-box !important; word-wrap: break-word !important;">北京市进口医疗器械代理人管理办法（征求意见稿）</span></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);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /><span style="max-width: 100%; color: rgb(64, 118, 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;">第一章总则</strong></span><br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第一条 </strong>为规范进口医疗器械生产企业在北京市辖区内设立的代表机构或者指定的北京市辖区内企业法人（以下简称代理人）的行为，根据《医疗器械监督管理条例》、《医疗器械注册管理办法》及《体外诊断试剂注册管理办法》，制定本办法。<br 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;" /> 医疗器械生产企业为香港、澳门、台湾地区的，参照进口医疗器械管理。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第二条 </strong>本办法中代理人是指医疗器械产品注册证上“代理人住所”在北京市行政区域内，由境外申请人或备案人设立的代表机构或者指定企业法人。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第三条 </strong>代理人应当按本办法要求配合境外申请人或备案人进行相关工作，行使代理人的权利和承担代理人义务。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第四条</strong><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"> </strong>北京市食品药品监督管理局负责组织全市代理人监督管理工作，区局、直属分局负责本辖区内的代理人日常监督管理工作。<br 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;" /><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(64, 118, 0); box-sizing: border-box !important; word-wrap: break-word !important;">第二章医疗器械代理人信息管理</span></strong><br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第五条</strong> 代理人在取得医疗器械产品注册后，应及时将产品注册证载明信息等信息（具体见附件）通过市食药局企业服务平台上报。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"> 第六条</strong> 医疗器械注册证载明的代理人发生变更的，应按照相关法规要求进行注册/备案变更，变更后的代理人应按照本办法第五条要求上报相关信息。原代理人应书面告知所属区局或直属分局。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第七条</strong> 注册证书载明的其他信息及代理人基本信息发生变更的，代理人应及时通过市食药局企业服务平台上报。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第八条 </strong>区局、直属分局对辖区代理人上报的信息进行核对，并对信息进行管理。<br 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;" /><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(64, 118, 0); box-sizing: border-box !important; word-wrap: break-word !important;">第三章医疗器械代理人职责</span></strong><br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第九条</strong> 代理人在产品注册或备案过程中，应按照相关法规要求开展注册检验、临床试验、产品注册或备案等工作。<br 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;" /> 代理人开展临床试验，应按照《医疗器械注册管理办法》、《体外试剂注册管理办法》和《医疗器械临床试验质量管理规范》的要求，在有资质的临床试验机构进行，并向北京市食品药品监督管理局备案。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十条</strong> 代理人应按照《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》的要求，履行向申请人或者备案人如实、准确传达相关的法规和技术要求义务；履行与相应食品药品监督管理部门、境外申请人或者备案人联络的义务；并承担其他涉及产品质量和售后服务的连带责任。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十一条</strong> 医疗器械代理人应当按照医疗器械不良事件监测和再评价的相应规定，建立组织机构、监测制度，收集本企业上市医疗器械产品不良事件信息并按要求上报，配合监管部门做好医疗器械不良事件相关调查、分析和评价工作和产品再评价工作。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"> 第十二条</strong> 代理人应按照《医疗器械注册管理办法》中相关要求，协调做好医疗器械上市后的产品召回工作。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十三条</strong> 对使用单位委托维修服务机构或者自行对在用医疗器械进行维护维修的，医疗器械代理人应当按照《医疗器械使用质量监督管理办法》的要求，按照合同的约定提供维护手册、维修手册、软件备份、故障代码表、备件清单、零部件、维修密码等维护维修必需的材料和信息给相关单位。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十四</strong><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">条</strong> 代理人应按照《医疗器械质量监督抽验管理办法》的要求，配合食品药品监督管理部门开展医疗器械产品质量监督抽查检验或评价。<br 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 style="max-width: 100%; color: rgb(64, 118, 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;">第四章监督管理</strong></span><br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十五条</strong> 北京市食品药品监督管理局负责对本市代理人注册与备案相关工作实施日常监督管理，及时向国家食品药品监督管理总局通报相关信息；开展临床试验的核查；组织代理人信息管理工作；将进口医疗器械注册证或变更批件移送给相关区局、直属分局。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十六条</strong> 区局、直属分局收到市局移送的进口医疗器械产品注册证后，负责代理人信息核对确认；并应将代理人监督管理纳入日常监督管理工作，对本辖区内代理人开展日常监督检查、产品抽验等工作，并监督代理人开展产品召回、不良事件监测等工作。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十七条</strong> 食品药品监督管理部门对代理人开展监督检查时，发现代理人发生变化未办理医疗器械注册证登记事项变更的，按照《医疗器械监督管理条例》第六十五条有关未备案的情形予以处罚同时通报国家总局。涉及外埠的，由市食药局将相关情况通报国家食品药品监督管理总局及相关省局。<br 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;" /><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(64, 118, 0); box-sizing: border-box !important; word-wrap: break-word !important;">第五章附则</span></strong><br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十八条</strong> 本办法由北京市食品药品监督管理局负责解释。<br 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;" /> <strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第十九条</strong> 本办法自发布之日起实施。<br 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 style="max-width: 100%; color: rgb(2, 30, 170); 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;">附件</strong></span></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%; color: rgb(2, 30, 170); 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;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(2, 30, 170); 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;"><img data-w="" data-ratio="1.7284172661870503" data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/2OZNJAdjibAxYQlibv3HHFVKJFMn7XDOdsgBaeyq69KYXxHovdSaicE2qW4LLOb9vTcyIQ0LPYrXOl00QCa1tGVXg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /></strong></span></p><section class="pEditor " style="line-height: 25.6px; white-space: normal;"><section data-css="background-color: rgb(239, 239, 239);border-radius: 5px;border: 1px solid rgb(153, 153, 152);margin: 0px;padding: 5px" style="padding: 5px; border-radius: 5px; border: 1px solid rgb(131, 147, 209); text-align: center; background-color: rgb(239, 239, 239);"><section data-css="color: inherit;display: inline-block;margin: 1px" style="margin: 1px; color: inherit; display: inline-block;"><span style="padding: 2px 10px; border-color: rgb(204, 204, 204); border-radius: 2px; color: rgb(1, 1, 3); font-weight: bold; font-size: 18px; background-color: rgb(109, 205, 25);">推荐阅读</span></section><section data-css="color: inherit;margin: 0px;padding: 10px" style="padding: 10px; color: inherit;"><p style="line-height: 1.75em; text-align: left;"></p><p style="line-height: 1.75em;">看看医院到底在用啥设备？</p><p style="line-height: 1.75em;">什么是医疗器械维修工程师<br /></p><p style="line-height: 1.75em;">逆天！！GE医疗居然如此翻新CT（视频）<br /></p><p style="line-height: 1.75em;">我老公是做医疗器械的（疯传医疗圈）<br /></p><p style="line-height: 1.75em;">触目惊心: 西方卖中国一把刀竟然勒索13亿</p></section></section></section><p style="line-height: 25.6px;"><br /></p><p><br /></p><section class="pEditor " style="line-height: 25.6px; 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发表于 2020-10-21 13:00:28