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医疗器械经营企业分类分级监督管理规定

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发表于 2020-10-19 22:43:11 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p><img data-type="gif" class="__bg_gif " data-ratio="0.10555555555555556" data-w="720" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/640?wx_fmt=gif" style="white-space: normal;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;"  /></p><p><span style="color: rgb(136, 136, 136);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-size: 12px;">来源:NMPA</span></p><section style="margin-top: 15px;margin-bottom: 15px;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">第一章  总则</span></strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第一条 为提高医疗器械经营企业监督管理科学化水平,明确各级食品药品监督管理部门的监管责任,提升监管效能,保证公众用械安全,根据《医疗器械监督管理条例》及《医疗器械经营监督管理办法》等,制定本规定。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">第二条 本规定中的分类分级监督管理,是指食品药品监督管理部门根据医疗器械的风险程度、医疗器械经营企业业态、质量管理水平和遵守法规的情况,结合医疗器械不良事件及产品投诉状况等因素,将医疗器械经营企业分为不同的类别,并按照属地监管的原则,实施分级动态管理的活动。</span><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第三条 本规定适用于各级食品药品监督管理部门对医疗器械经营企业分类分级监督管理活动的全过程。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第四条 国家食品药品监督管理总局负责指导和检查全国医疗器械经营企业分类分级监督管理工作。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">省级食品药品监督管理部门负责编制本省的医疗器械经营企业监督检查计划,并监督实施医疗器械经营企业分类分级监督管理工作。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">设区的市级食品药品监督管理部门结合实际确定本行政区域内医疗器械经营企业的监管级别,明确监管重点,规定检查频次和覆盖率,并组织实施。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">县(区)级食品药品监督管理部门负责本行政区域内医疗器械经营企业分类分级监督管理的具体工作。</span></section><section style="margin-top: 15px;margin-bottom: 15px;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">第二章 经营企业的分类分级</span></strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第五条 国家食品药品监督管理总局根据经营环节产品的特殊储运要求和监督抽验、不良事件监测、风险监测、召回等情况,以及质量投诉多、社会关注度高的产品,制定公布《医疗器械经营环节重点监管目录及现场检查重点内容》。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">第六条 医疗器械经营企业分为</span><span style="max-width: 100%;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">三个监管级别。<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></span><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(255, 41, 65);box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></span></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;">三级监管为风险最高级别的监管</span>,主要是对医疗器械经营环节重点监管目录涉及的经营企业,为其他医疗器械生产经营企业提供贮存、配送服务的经营企业,上年度存在行政处罚且整改不到位和存在不良信用记录的经营企业进行的监管。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">二级监管为风险一般级别的监管,主要是对除三级监管外的经营第二、三类医疗器械的批发企业进行的监管。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">一级监管为风险较低级别的监管,主要是对除二、三级监管外的其他医疗器械经营企业进行的监管。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">医疗器械经营企业涉及多个监管级别的,按最高级别对其进行监管。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第七条 医疗器械经营企业监管级别确定工作按年度进行并向社会公布,对于企业存在严重违法违规行为或新增经营业态等特殊情况可即时确定并调整企业监管级别。各级食品药品监督管理部门按照确定的级别进行相应的监督管理。</span></section><section style="margin-top: 15px;margin-bottom: 15px;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">第三章 监管措施</span></strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第八条 地方各级食品药品监督管理部门应当督促医疗器械经营企业按照《医疗器械经营质量管理规范》要求,采取有效的质量控制措施,保障经营过程中产品的质量安全,防止发生重大医疗器械质量事故。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第九条 地方各级食品药品监督管理部门根据监管级别,制定监督计划,综合运用全项目检查、飞行检查、跟踪检查和监督抽验等多种形式强化监督管理。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十条 设区的市级食品药品监督管理部门应结合监管实际,依据确定的监管级别,制定本行政区域内医疗器械经营企业的监督检查频次和覆盖率,原则要求如下:<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(69, 67, 67);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">(一)实施</span><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">三级监管的经营企业,设区的市级食品药品监督管理部门组织每年检查不少于一次,角膜接触镜类和计划生育类产品各地可根据监管需要确定检查频次。对整改企业跟踪检查覆盖率要达到100%,直至企业整改到位。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(69, 67, 67);"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">(二)实施二级监管的经营企业,县(区)级食品药品监督管理部门每两年检查不少于一次。</span><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">对整改企业跟踪检查覆盖率要达到100%,直至企业整改到位。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="color: rgb(69, 67, 67);"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">(三)实施一级监管的经营企业,县(区)级食品药品监督管理部门按照有关要求,随机抽取本行政区域内30%以上的企业进行监督检查,3年内达到全覆盖。</span><strong><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></span></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十一条 省级食品药品监督管理部门应当每年随机抽取本行政区域内一定比例的医疗器械经营企业进行监督检查。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十二条 对于经营企业发生重大质量事故,省级食品药品监督管理部门应当及时组织检查,并同时上报国家食品药品监督管理总局。一般质量事故由设区的市级食品药品监督管理部门组织检查。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十三条 地方各级食品药品监督管理部门对于监管中发现的共性问题、突出问题或企业质量管理薄弱环节,要结合本行政区域的监管实际,制定加强监管的措施并组织实施。涉及重大问题的,应当及时向上一级食品药品监督管理部门报告。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十四条 地方各级食品药品监督管理部门应当及时主动向社会公开监督检查的结果、对企业经营的产品开展抽验的结果、查处的意见等监管信息,合格的、不合格的企业都要公开。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十五条 设区的市级及以下食品药品监督管理部门应当建立本行政区域内医疗器械经营企业分类分级监督管理档案。监督管理档案应当包括医疗器械经营企业许可和备案、监督检查、监督抽验、不良事件监测、产品召回、处罚情况和投诉举报等信息,同时应当录入医疗器械经营企业监管信息系统并定期更新,确保相关信息及时、准确。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十六条 上级食品药品监督管理部门应采取措施,对下级食品药品监督管理部门开展医疗器械经营企业分类分级监督管理工作进行督查,落实监管责任。对监管责任落实不到位的,可以通报当地政府。</span></section><section style="margin-top: 15px;margin-bottom: 15px;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">第四章 附则</span></strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;letter-spacing: 0.544px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">第十七条 地方各级食品药品监督管理部门对医疗器械经营企业实施的监督检查主要包括</span><span style="letter-spacing: 0.544px;max-width: 100%;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">全项目检查、飞行检查、跟踪检查</span><span style="font-size: 14px;letter-spacing: 0.544px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">等。<br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">全项目检查是指按照医疗器械经营质量管理规范逐条开展的检查。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">本规定</span><span style="max-width: 100%;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">飞行检查</span><span style="font-size: 14px;"><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">是指针对医疗器械经营企业开展的不预先告知的监督检查。<br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></span><span style="max-width: 100%;color: rgb(255, 41, 65);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></strong></span></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">跟踪检查</span><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">是指对医疗器械经营企业有关问题的整改措施与整改效果的复核性检查。</span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></span></section><section style="max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5em;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;">第十八条 本规定自发布之日起施行。</span></section><p><br  /></p><p><br  /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">赞<span style="max-width: 100%;line-height: 25px;">是一种友谊 |&nbsp;<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">分享</strong>传递智慧</span></span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;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;"><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);line-height: 24.381px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;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></strong></span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;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;"><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);line-height: 24.381px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;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%;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></strong></span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;text-indent: 0em;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">地址:广州市天河区高塘路235号时代E-PARK7栋801、802室&nbsp; &nbsp; &nbsp;</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">邮编:510507</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">电话:(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">传真:020-8722 8623</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">全国统一免费服务热线:400-020-6788</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 24.381px;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">公司官网:http://www.parts-ultrasound.com/</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;text-indent: 0em;font-family: Arial, Verdana, sans-serif;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">微信公众帐号:</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-size: 16px;text-align: left;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="rich_pages " data-ratio="1" data-s="300,640" data-type="png" data-w="344" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcvQ5W66skZY3mYSqpoRYIMn3LOS0l9GkWVqSdiaw2RiclU8MiatfDmia3YvXxPRgDFiaZFibgUOEEfaYhA/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 344px !important;"  /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">维修咨询:QQ: &nbsp;712638 404</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">设备咨询: &nbsp; QQ: &nbsp;712638 405</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询:QQ: 712638 406</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">配件咨询:QQ: &nbsp; 712638 407</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">交流Q群:1106 11074</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址:https://renchengyiliao.1688.com</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);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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