|
|
<p style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", " ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 12px;color: rgb(136, 136, 136);box-sizing: border-box !important;word-wrap: break-word !important;">来源：国家药品监督管理局</span></p><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;vertical-align: middle;display: inline-block;word-wrap: break-word !important;"><img data-ratio="0.625" data-type="jpeg" data-w="400" class="" src="http://mmbiz.qpic.cn/mmbiz_jpg/5MMg4fDyJ8Sw17ADk4AqnVlWdtelB5iaibY9LALjh3Kt7dVUZGWR9Scz17SYOuc1ZaBZXsc3h0qnSOPKMrRRGOHw/640?wx_fmt=jpeg" style="box-sizing: border-box;vertical-align: middle;word-wrap: break-word !important;width: 400px !important;visibility: visible !important;" /></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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="padding: 10px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-width: 1px;border-style: solid;border-color: rgb(226, 226, 226);box-shadow: rgb(226, 226, 226) 0px 16px 1px -13px;word-wrap: break-word !important;"><section class="" powered-by="gulangu" style="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;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">为贯彻实施《医疗器械监督管理条例》《国家创新驱动发展战略》，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》和国务院《关于改革药品医疗器械审评审批制度的意见》，国家药监局积极实施创新医疗器械特别审批程序，鼓励医疗器械研发创新，取得了良好成效。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"> </p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">2014年2月7日，原国家食品药品监督管理总局发布了《创新医疗器械特别审批程序（试行）》，自2014年3月1日起施行。针对具有我国发明专利、技术上具有国内首创、国际领先水平，并且具有显著临床应用价值的医疗器械设置特别审批通道。该程序的实施对医疗器械研发创新、新技术推广应用、产业高质量发展起到了积极推动作用。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"> </p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">为深入推进审评审批制度改革，鼓励医疗器械创新，深化供给侧结构性改革和“放管服”改革要求，激励产业创新高质量发展，国家药监局多次开展调研，组织专题研究，多方征求意见，对程序进行研究修改，于近日发布了<strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(51, 66, 159);word-wrap: break-word !important;">新修订的《创新医疗器械特别审查程序》，自2018年12月1日起施行</span></strong>。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"> </p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">新修订的《创新医疗器械特别审查程序》完善了适用情形、细化了申请流程、提升了创新审查的实效性、完善了审查方式和通知形式，并明确对创新医疗器械的许可事项变更优先办理。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"> </p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">修订的《创新医疗器械特别审查程序》，程序设置更为科学有效，有利于提升创新医疗器械审查效率，为鼓励医疗器械产业创新发展发挥积极作用。</p></section></section></section></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><section style="margin-top: 0.5em;margin-bottom: 0.5em;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-radius: 0.5em 0.5em 0px 0px;background-color: rgba(97, 139, 182, 0.75);word-wrap: break-word !important;"><section class="" powered-by="gulangu" style="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="padding: 5px 10px;max-width: 100%;box-sizing: border-box;text-align: center;color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">国家药品监督管理局关于发布创新医疗器械特别审查程序的公告</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（2018年第83号）</p></section></section></section></section><section style="max-width: 100%;box-sizing: border-box;border-radius: 0px 0px 0.5em 0.5em;border-right: 1px solid rgb(192, 200, 209);border-top-style: none;border-bottom: 1px solid rgb(192, 200, 209);border-left: 1px solid rgb(192, 200, 209);border-top-color: rgb(192, 200, 209);word-wrap: break-word !important;"><section class="" powered-by="gulangu" style="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="padding: 5px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">为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），鼓励医疗器械研发创新，促进医疗器械新技术的推广和应用，推动医疗器械产业高质量发展，国家药品监督管理局组织修订了《创新医疗器械特别审查程序》，现予发布，自2018年12月1日起施行。原国家食品药品监督管理总局印发的《创新医疗器械特别审批程序（试行）》（食药监械管〔2014〕13号）同时废止。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"> 特此公告。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;text-align: right;word-wrap: break-word !important;">国家药监局</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;text-align: right;word-wrap: break-word !important;">2018年11月2日</p></section></section></section></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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;display: inline-block;vertical-align: top;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: middle;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">附件</strong></p></section><section style="margin-right: 3px;margin-left: 5px;max-width: 100%;box-sizing: border-box;width: 0px;border-left: 8px solid rgb(51, 66, 159);border-top: 5px solid transparent;border-bottom: 5px solid transparent;display: inline-block;vertical-align: middle;word-wrap: break-word !important;"></section><section style="margin-right: -9px;max-width: 100%;box-sizing: border-box;width: 0px;border-left: 8px solid rgb(255, 255, 255);border-top: 4px solid transparent;border-bottom: 4px solid transparent;display: inline-block;vertical-align: middle;transform: rotate(0deg);word-wrap: break-word !important;"></section><section style="max-width: 100%;box-sizing: border-box;width: 0px;border-left: 10px solid rgb(51, 66, 159);border-top: 6px solid transparent;border-bottom: 6px solid transparent;display: inline-block;vertical-align: middle;word-wrap: break-word !important;"></section></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;word-wrap: break-word !important;"><section style="margin-bottom: -10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="margin-left: 5px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: bottom;width: 6px;word-wrap: break-word !important;"><section style="margin: auto;max-width: 100%;box-sizing: border-box;width: 2px;height: 16px;background-color: rgb(17, 19, 22);word-wrap: break-word !important;"></section><section style="max-width: 100%;box-sizing: border-box;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(17, 19, 22);word-wrap: break-word !important;"></section></section><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: bottom;width: 47.0938px;word-wrap: break-word !important;"></section><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: bottom;width: 6px;word-wrap: break-word !important;"><section style="margin: auto;max-width: 100%;box-sizing: border-box;width: 2px;height: 16px;background-color: rgb(17, 19, 22);word-wrap: break-word !important;"></section><section style="max-width: 100%;box-sizing: border-box;width: 6px;height: 6px;border-radius: 50%;background-color: rgb(17, 19, 22);word-wrap: break-word !important;"></section></section></section><section style="margin-bottom: -5px;max-width: 100%;box-sizing: border-box;transform: rotate(0deg);width: 5px;height: 5px;word-wrap: break-word !important;"></section><section style="max-width: 100%;box-sizing: border-box;border-left: 5px solid rgba(19, 129, 236, 0.6);border-top-color: rgba(19, 129, 236, 0.6);border-right-color: rgba(19, 129, 236, 0.6);border-bottom: 5px solid rgba(19, 129, 236, 0.6);word-wrap: break-word !important;"><section style="padding: 10px 10px 2px;max-width: 100%;box-sizing: border-box;color: rgb(255, 255, 255);background-color: rgb(51, 66, 159);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">创新医疗器械特别审查程序</strong></p></section></section><section style="margin-top: -5px;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;word-wrap: break-word !important;"></section></section></section></section><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 17px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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="padding: 10px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-width: 1px;border-style: solid;border-color: rgba(18, 101, 186, 0.85);word-wrap: break-word !important;"><section class="" powered-by="gulangu" style="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;word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第一条</strong> 为了保障医疗器械的安全、有效，鼓励医疗器械的研究与创新，促进医疗器械新技术的推广和应用，推动医疗器械产业发展，根据《医疗器械监督管理条例》《医疗器械注册管理办法》《体外诊断试剂注册管理办法》等法规和规章，制定本程序。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二条</strong> 符合下列情形的医疗器械审查，适用于本程序：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（一）申请人通过其主导的技术创新活动，在中国依法拥有产品核心技术发明专利权，或者依法通过受让取得在中国发明专利权或其使用权，创新医疗器械特别审查申请时间距专利授权公告日不超过5年；或者核心技术发明专利的申请已由国务院专利行政部门公开，并由国家知识产权局专利检索咨询中心出具检索报告，报告载明产品核心技术方案具备新颖性和创造性。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（二）申请人已完成产品的前期研究并具有基本定型产品，研究过程真实和受控，研究数据完整和可溯源。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（三）产品主要工作原理或者作用机理为国内首创，产品性能或者安全性与同类产品比较有根本性改进，技术上处于国际领先水平，且具有显著的临床应用价值。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第三条</strong> 药品监督管理部门及相关技术机构，根据各自职责和本程序规定，按照早期介入、专人负责、科学审查的原则，在标准不降低、程序不减少的前提下，对创新医疗器械予以优先办理，并加强与申请人的沟通交流。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第四条</strong> 申请人申请创新医疗器械特别审查，应当在第二类、第三类医疗器械首次注册申请前，填写《创新医疗器械特别审查申请表》（见附1），并提交支持拟申请产品符合本程序第二条要求的资料。资料应当包括：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（一）申请人企业资质证明文件。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（二）产品知识产权情况及证明文件。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（三）产品研发过程及结果综述。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（四）产品技术文件，至少应当包括：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">1.产品的适用范围或者预期用途；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">2.产品工作原理或者作用机理；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">3.产品主要技术指标及确定依据，主要原材料、关键元器件的指标要求，主要生产工艺过程及流程图，主要技术指标的检验方法。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（五）产品创新的证明性文件，至少应当包括：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">1.核心刊物公开发表的能够充分说明产品临床应用价值的学术论文、专著及文件综述；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">2.国内外已上市同类产品应用情况的分析及对比（如有）；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">3.产品的创新内容及在临床应用的显著价值。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（六）产品风险分析资料。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（七）产品说明书（样稿）。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（八）其他证明产品符合本程序第二条的资料。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（九）所提交资料真实性的自我保证声明。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">境外申请人应当委托中国境内的企业法人作为代理人或者由其在中国境内的办事机构提出申请，并提交以下文件：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">1.境外申请人委托代理人或者其在中国境内办事机构办理创新医疗器械特别审查申请的委托书；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">2.代理人或者申请人在中国境内办事机构的承诺书；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">3.代理人营业执照或者申请人在中国境内办事机构的机构登记证明。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">申报资料应当使用中文。原文为外文的，应当有中文译本。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第五条</strong> 境内申请人应当向其所在地的省级药品监督管理部门提出创新医疗器械特别审查申请。省级药品监督管理部门对申报项目是否符合本程序第二条要求进行初审，并于20个工作日内出具初审意见。经初审不符合第二条要求的，省级药品监督管理部门应当告知申请人；符合第二条要求的，省级药品监督管理部门将申报资料和初审意见一并报送国家药品监督管理局行政事项受理服务和投诉举报中心（以下简称受理和举报中心）。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">境外申请人应当向国家药品监督管理局提出创新医疗器械特别审查申请。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第六条</strong> 受理和举报中心对创新医疗器械特别审查申请申报资料进行形式审查，对符合本程序第四条规定的形式要求的予以受理，并给予受理编号，编排方式为：CQTS××××1×××2，其中××××1为申请的年份；×××2为产品流水号。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">对于已受理的创新医疗器械特别审查申请，申请人可以在审查决定作出前，申请撤回创新医疗器械特别审查申请及相关资料，并说明理由。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第七条 </strong>国家药品监督管理局医疗器械技术审评中心（以下简称器审中心）设立创新医疗器械审查办公室，对创新医疗器械特别审查申请进行审查。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第八条</strong> 创新医疗器械审查办公室收到创新医疗器械特别审查申请后，组织专家进行审查。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">申请资料存在以下五种情形之一的，创新医疗器械审查办公室不组织专家进行审查：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">1.申请资料虚假的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">2.申请资料内容混乱、矛盾的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">3.申请资料的内容与申报项目明显不符的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">4.申请资料中产品知识产权证明文件不完整、专利权不清晰的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">5.前次审查意见已明确指出产品主要工作原理或者作用机理非国内首创，且再次申请时产品设计未发生改变的。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第九条</strong> 创新医疗器械审查办公室收到创新医疗器械特别审查申请后，应当于60个工作日内出具审查意见（公示及异议处理时间不计算在内）。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十条</strong> 经创新医疗器械审查办公室审查，对拟进行特别审查的申请项目，应当在器审中心网站将申请人、产品名称予以公示，公示时间应当不少于10个工作日。对于公示内容有异议的，应当对相关意见研究后作出最终审查决定。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十一条</strong> 创新医疗器械审查办公室作出审查决定后，将审查结果通过器审中心网站告知申请人。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">审查结果告知后5年内，未申报注册的创新医疗器械，不再按照本程序实施审查。5年后，申请人可按照本程序重新申请创新医疗器械特别审查。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十二条</strong> 经审查拟同意进行特别审查的申请项目，创新医疗器械审查办公室在出具审查意见时一并对医疗器械管理类别进行界定。所申请创新医疗器械的管理属性存在疑问的，申请人应当先进行属性界定后再提出创新医疗器械特别审查申请。对于境内企业申请，如产品被界定为第二类医疗器械，相应的省级药品监督管理部门可参照本程序进行审查。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十三条</strong> 对于经审查同意按本程序审查的创新医疗器械，申请人所在地省级药品监督管理部门应当指定专人，应申请人的要求及时沟通、提供指导。在收到申请人质量管理体系核查申请后，应当予以优先办理。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十四条</strong> 对于创新医疗器械，医疗器械检验机构在进行检验时，应当优先进行检验，并出具检验报告。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十五条</strong> 创新医疗器械的临床试验应当按照医疗器械临床试验相关规定的要求进行，药品监督管理部门应当根据临床试验的进程进行监督检查。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十六条</strong> 创新医疗器械临床研究工作需重大变更的，如临床试验方案修订，使用方法、规格型号、预期用途、适用范围或人群的调整等，申请人应当评估变更对医疗器械安全性、有效性和质量可控性的影响。产品主要工作原理或者作用机理发生变化的创新医疗器械，应当按照本程序重新申请。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十七条</strong> 对于创新医疗器械，在产品注册申请受理前以及技术审评过程中，器审中心应当指定专人，应申请人的要求及时沟通、提供指导，共同讨论相关技术问题。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十八条</strong> 对于创新医疗器械，申请人在注册申请受理前以及技术审评过程中可填写创新医疗器械沟通交流申请表（见附2），就下列问题与器审中心沟通交流：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（一）重大技术问题；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（二）重大安全性问题；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（三）临床试验方案；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（四）阶段性临床试验结果的总结与评价；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（五）其他需要沟通交流的重要问题。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第十九条</strong> 器审中心应当对申请人提交的沟通交流申请及相关资料及时进行审核，并将审核结果告知申请人（见附3）。器审中心同意进行沟通交流的，应当明确告知申请人拟讨论的问题，与申请人商定沟通交流的形式、时间、地点、参加人员等，并安排与申请人沟通交流。沟通交流应当形成记录，记录需经双方签字确认，供该产品的后续研究及审评工作参考。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十条</strong> 受理和举报中心受理创新医疗器械注册申请后，应当将该注册申请项目标记为“创新医疗器械”，并及时进行注册申报资料流转。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十一条</strong> 器审中心对已受理注册申报的创新医疗器械，应当优先进行技术审评；技术审评结束后，国家药品监督管理局优先进行行政审批。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十二条</strong> 属于下列情形之一的，国家药品监督管理局可终止本程序并告知申请人：</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（一）申请人主动要求终止的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（二）申请人未按规定的时间及要求履行相应义务的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（三）申请人提供伪造和虚假资料的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（四）全部核心技术发明专利申请被驳回或视为撤回的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（五）失去产品全部核心技术发明专利专利权或者使用权的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（六）申请产品不再作为医疗器械管理的；</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;">（七）经专家审查会议讨论确定不宜再按照本程序管理的。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十三条 </strong>国家药品监督管理局在实施本程序过程中，应当加强与有关部门的沟通和交流，及时了解创新医疗器械的研发进展。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十四条</strong> 按本程序审查获准注册的医疗器械申请许可事项变更的，国家药品监督管理局予以优先办理。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十五条</strong> 突发公共卫生事件应急所需医疗器械，按照《医疗器械应急审批程序》办理。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十六条 </strong>本程序对创新医疗器械注册管理未作规定的，按照《医疗器械注册管理办法》等相关规定执行。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十七条</strong> 省、自治区、直辖市药品监督管理部门可参照本程序开展行政区域内第二类创新医疗器械特别审查工作。</p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;" /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">第二十八条</strong> 本程序自2018年12月1日起施行。原国家食品药品监督管理总局印发的《创新医疗器械特别审批程序（试行）》（食药监械管〔2014〕13号）同时废止。</p></section></section></section></section></section></section><p><br /></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);text-align: center;font-family: 微软雅黑;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);text-align: center;font-family: 微软雅黑;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);text-align: center;font-family: 微软雅黑;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: 微软雅黑;line-height: 2em;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：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 </span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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://www.parts-ultrasound.com/</span><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"></span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: 微软雅黑;line-height: 2em;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);line-height: 25.6px;text-align: center;font-family: 微软雅黑;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="" data-ratio="1" data-s="300,640" data-type="jpeg" data-w="258" width="auto" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvfh2wVX4NftfnfjcZWIKK6EQDWtTTsYwjfQBnsqkThAZP5OlDmg5S3g22gSqMWhAxr2O4MydSJHnQ/640?wx_fmt=jpeg" style="float: left;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: 微软雅黑;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;text-indent: 0em;white-space: normal;font-size: 12px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: Arial, Verdana, sans-serif;line-height: 2em;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>
|
|
发表于 2020-10-19 22:47:19