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<p><img src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/640?wx_fmt=gif" data-type="gif" class="" data-ratio="0.10555555555555556" data-w="720" data-backw="558" data-backh="59" style="width: 100%;height: auto;" /></p><section data-role="outer" label="Powered by gulangu" style="max-width: 100%;color: rgb(51, 51, 51);"><section data-role="paragraph" class="" style="max-width: 100%;border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;color: rgb(63, 63, 63);box-sizing: border-box !important;word-wrap: break-word !important;">5月7日晚间，国家药监局发布~5月7日晚间，国家药监局官网发布《国家药品监督管理局办公室关于公开征求《创新医疗器械特别审批程序(修订稿征求意见稿)》的意见》(以下简称《意见》)。</span></p><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;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="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="" data-ratio="0.3025210084033613" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_png/YbTq6LNicqJ6wxngdmtQvmC8D1OcR6UgMicHmzssyDB2h8aghOLXR2OyTnq8auxlmhseSJsH5B9QOFesib2N3toYg/640?" data-type="png" data-w="833" style="box-shadow: rgb(170, 170, 170) 0em 0em 1em 0px;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;text-align: center;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="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;color: rgb(63, 63, 63);box-sizing: border-box !important;word-wrap: break-word !important;">《意见》明确，为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，</span><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(63, 63, 63);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(192, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;">对同时符合下列情形的第二类、第三类医疗器械按本程序实施审评审批</span></strong></span><span style="max-width: 100%;color: rgb(63, 63, 63);box-sizing: border-box !important;word-wrap: break-word !important;">：</span></span></p><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;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><section class="" data-tools="gulangu" data-id="91148" data-color="#374aae" data-custom="#374aae" style="max-width: 100%;border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding: 10px 20px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding: 15px;max-width: 100%;border-width: 1px;border-style: solid;border-color: rgb(55, 74, 174);box-sizing: border-box !important;word-wrap: break-word !important;"><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;width: 596px;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(63, 63, 63);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">(一)申请人经过其主导的技术创新活动，<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(192, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;">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</span></strong>，专利的申请日(有优先权的按优先权日)在创新医疗器械特别审批程序申请5年内；或者<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(192, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;">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，检索报告中产品核心技术方案为具备新颖性和创造性</span></strong>。</span></p><section class="" data-width="100%" style="margin-top: 20px;margin-bottom: 20px;max-width: 100%;width: 596px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(63, 63, 63);box-sizing: border-box !important;word-wrap: break-word !important;">(二)<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(192, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;">产品主要工作原理/作用机理为国内首创</span></strong>，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，并且具有显著的临床应用价值。</span></p><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;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="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;text-align: justify;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(63, 63, 63);box-sizing: border-box !important;word-wrap: break-word !important;">(三)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。</span></p></section></section></section></section></section></section><p style="padding-right: 0.5em;padding-left: 0.5em;max-width: 100%;min-height: 1em;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="padding-right: 0.5em;padding-left: 0.5em;max-width: 100%;min-height: 1em;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">附件：</strong></p><p style="max-width: 100%;min-height: 1em;"></p><section style="max-width: 100%;color: rgb(51, 51, 51);"><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" style="margin-top: 0.5em;margin-bottom: 0.5em;max-width: 100%;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-top: -20px;margin-bottom: -20px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" style="padding: 10px 20px;max-width: 100%;border-width: 2px;border-style: dotted;border-color: rgb(233, 233, 233);box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" powered-by="gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;clear: none;min-height: 1em;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">创新医疗器械特别审批程序</span></strong></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;clear: none;min-height: 1em;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;color: rgb(40, 36, 36);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%;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">(修订稿征求意见稿)</span></strong></span></p></section></section></section></section></section><section style="max-width: 100%;width: 20px;height: 20px;float: left;border-bottom: 2px solid rgb(197, 38, 12);border-left: 2px solid rgb(197, 38, 12);box-sizing: border-box !important;word-wrap: break-word !important;"></section><section style="max-width: 100%;width: 20px;height: 20px;float: right;border-bottom: 2px solid rgb(197, 38, 12);border-right: 2px solid rgb(197, 38, 12);box-sizing: border-box !important;word-wrap: break-word !important;"></section><section style="max-width: 100%;clear: both;box-sizing: border-box !important;word-wrap: break-word !important;"></section></section></section></section></section><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第一条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 药品监督管理部门对同时符合下列情形的第二类、第三类医疗器械按本程序实施审评审批：</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(一)申请人经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，专利的申请日(有优先权的按优先权日)在创新医疗器械特别审批程序申请5年内;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，检索报告中产品核心技术方案为具备新颖性和创造性。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(二)产品主要工作原理/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，并且具有显著的临床应用价值。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(三)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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第三条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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、科学审批的原则，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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第四条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 申请人申请创新医疗器械特别审批，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批申请表》(见附件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：</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(一)申请人企业法人资格证明文件。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(二)产品知识产权情况及证明文件。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(三)产品研发过程及结果的综述。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(四)产品技术文件，至少应当包括：</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">1.产品的适用范围/预期用途;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">2.产品工作原理/作用机理;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(五)产品创新的证明性文件，至少应当包括：</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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);</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">3.产品的创新内容及在临床应用的显著价值。</span><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> </span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(六)产品风险分析资料。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(七)产品说明书(样稿)。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(八)其他证明产品符合本程序第二条的资料。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(九)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：</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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批申请的委托书;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;letter-spacing: 1px;font-size: 14px;color: rgb(40, 36, 36);box-sizing: border-box !important;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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(十)所提交资料真实性的自我保证声明。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第五条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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批申请。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(以下简称国家药监局)行政受理服务中心。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">境外申请人应当向国家药监局提出创新医疗器械特别审批申请。国家药监局行政受理服务中心对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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">对于已受理的创新医疗器械特别审批申请，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批申请及相关资料，并说明理由。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第六条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 国家药监局行政受理服务中心对受理的特别审批申请，给予产品特别审批申请受理编号，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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第七条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 国家药监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批申请进行审查。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第八条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 国家药监局行政受理服务中心受理创新医疗器械特别审批申请后，由创新医疗器械审查办公室组织专家进行审查。创新医疗器械审查办公室收到创新医疗器械特别审批申请后，于40个工作日内组织专家进行审查;专家审查后20个工作日内出具审查意见。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第九条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 经创新医疗器械审查办公室审查，对拟进行特别审批的申请项目，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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">审查结果告知后3年内，相应医疗器械未申报注册的，不再按照本程序实施审评审批。3年后，申请人还可按照本程序重新申请创新医疗器械特别审批。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十一条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 创新医疗器械审查办公室在审查创新医疗器械特别审批申请时一并对医疗器械管理类别进行界定。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评审批。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十二条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 对于经审查同意按本程序审批的创新医疗器械，申请人所在地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。在对申请人质量管理体系检查工作中，应当予以优先办理。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十三条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 对于创新医疗器械，医疗器械检验机构在进行检验时，应当及时对生产企业提交的产品技术要求进行预评价，并及时向申请人反馈。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十四条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 医疗器械检验机构应当在接受样品后优先进行检验，并出具检验报告。经过预评价的产品技术要求和预评价意见应当加盖与检验报告相同印章，随检验报告一同出具。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十五条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十六条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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作用机理发生变化的创新医疗器械，应当按照本审批程序重新申请。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十七条 </span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十八条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 在创新医疗器械审评过程中，申请人可填写创新医疗器械沟通交流申请表，就下列问题向器审中心沟通交流：</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(一)重大技术问题;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(二)重大安全性问题;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(三)临床试验方案;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(四)阶段性临床试验结果的总结与评价;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(五)其他需要沟通交流的重要问题。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第十九条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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。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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 国家药监局行政受理服务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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十一条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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，国家药监局优先进行行政审批。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十二条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 属于下列情形之一的，国家药监局可终止本程序并告知申请人：</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(一)申请人主动要求终止的;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;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;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(三)申请人提供伪造和虚假资料的;</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(四)核心技术发明专利申请被驳回或视为撤回的。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(五)失去产品核心技术发明专利专利权或者使用权的。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;">(六)申请产品不再作为医疗器械管理的。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;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。</span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十三条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 国家药监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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十四条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 按本程序审批获准注册的医疗器械申请许可事项变更的，国家药监局予以优先办理。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十五条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十六条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 医疗器械注册管理要求和规定，本程序未涉及的，按照《医疗器械注册管理办法》等相关规定执行。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十七条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 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批工作。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);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%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;">第二十八条</span></strong><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"> 本程序自2018年10月1日起施行。原国家食品药品监督管理总局2014年2月7日印发的《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。</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(40, 36, 36);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);text-align: right;"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;font-size: 12px;">来源：医疗器械经销商联盟</span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;font-size: 12px;"><br /></span></span></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(40, 36, 36);max-width: 100%;letter-spacing: 1px;font-size: 12px;"></span></span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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;"></strong></span></strong></strong></strong></span></strong></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></span></strong></span></strong></strong></strong></span></strong></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 </span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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://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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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;"><img class="" data-ratio="1" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvfh2wVX4NftfnfjcZWIKK6EQDWtTTsYwjfQBnsqkThAZP5OlDmg5S3g22gSqMWhAxr2O4MydSJHnQ/640?wx_fmt=jpeg" data-type="jpeg" data-w="258" style="float: left;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" width="auto" /></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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;"><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址：</span><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">https://renchengyiliao.1688.com</span></span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;white-space: normal;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>
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发表于 2020-10-19 22:52:26