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<p><br /><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-size: 15px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p><span style="font-size: 15px;">来源:中国医药报</span></p><p><span style="font-size: 15px;"><br /></span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><img class="" data-ratio="0.5638888888888889" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvcQfBWeOeL6EQotISletOpQZ4DVT3unNPSORHVhD2icUZck5VwK6sysvlW4nniadPelibzzibjlpLrfMA/640?wx_fmt=jpeg" data-type="jpeg" data-w="1080" style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 10px;margin-right: auto;margin-left: auto;display: block;" /></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(11, 11, 11);">《定制式医疗器械监督管理规定(试行)》已于日前出台,并将自2020年1月1日起施行。</span><span style="font-size: 15px;color: rgb(11, 11, 11);">《定制式医疗器械监督管理规定(试行)》与2017年中共中央办公厅、国务院办公厅印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》精神高度契合,同时也为适应医疗器械行业发展现状,充分释放医疗器械创新能力提供了法律法规上的支持。</span><span style="font-size: 15px;color: rgb(11, 11, 11);">对于定制式医疗器械这种创新产品监管,<span style="color: rgb(11, 11, 11);font-size: 15px;border-width: 0px;border-style: initial;border-color: initial;">既要扶持好新生事物,营造鼓励创新的氛围,又要保障其安全有效</span>。</span><span style="font-size: 15px;color: rgb(11, 11, 11);">如何做好定制式医疗器械的监督管理,值得探讨。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvcQfBWeOeL6EQotISletOpQQkW8m9yhOugEjZSb6CPnleicOj7105RrCrkm5fz1VlJRI3jicvFOeRkg/640?wx_fmt=jpeg" data-type="jpeg" data-w="826" style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 10px;margin-right: auto;margin-left: auto;display: block;" /></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-weight: 700;border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">个性化特点决定监管难点</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械是为满足指定患者的罕见特殊病损情况,基于特殊临床需求而设计和生产,用于指定患者的个性化医疗器械。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械的特点主要体现在以下几个方面。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第一,定制式医疗器械具有随机性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">患者的病损是随机的,无论是医疗机构还是监管部门对于患者的病情事先并不知情,对于定制式医疗器械而言,其适用的具体部位、形状及其他内容都是随机、不确定的。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第二,定制式医疗器械具有即时性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">患者病发到医疗机构就诊时,需要医疗机构尽快诊断、给出治疗方案。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">若需要定制式医疗器械予以治疗,医生给出个性化医疗器械的相关指标,生产企业需按医疗机构给出的指标立即组织生产,生产完成后即送至医疗机构为指定患者开展手术。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第三,定制式医疗器械具有精准性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械是针对特定患者的具体病损来设计、生产、制作的,只能用于指定患者的指定部位。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第四,定制式医疗器械具有交互性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械是医疗机构与生产企业共同完成设计的,生产企业的定制式医疗器械具体数据来源于医疗机构,生产企业生产出定制式医疗器械后,还需要医生用于具体患者,这是一个从医生到生产者,再从生产者到医生的交互过程。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: " ingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第五,定制式医疗器械的监管具有间接性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">与普通医疗器械不同的是,定制式医疗器械在制作完成后会立即用于临床,在监管工作中难以看到实物,在生产环节也无法留样,所以定制式医疗器械的设计、生产、使用记录等将以数字化状态存储,对其监督管理具有间接性。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">第六,定制式医疗器械具有非标性。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械是根据指定患者的罕见特殊病损制作的,并非按标准生产,不受医疗器械通用标准的规范,即使具有验收标准,也只是根据外观特征等简单的共性指标进行。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械的以上六个特性,决定了对其监管与普通医疗器械的不同。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械的随机性、即时性决定了无论在生产环节还是使用环节,监管人员很难看到实物,对定制式医疗器械的监管只能从医疗机构与生产企业之间传输的数据、成品的计算机数据以及生产记录入手。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">对医疗器械进行抽验,并根据抽验结果进行公告和监管,是发现不合格医疗器械产品,反映销售使用环节器械质量情况的重要依据和手段。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">医疗器械的抽验需要一定的样本量,同时还要遵循随机性、代表性的原则。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">但是,定制式医疗器械样本量小,且生产完成后会立即被使用于治疗患者疾病,监管人员无法通过抽验这一通用手段对定制式医疗器械进行监管。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">基于定制式医疗器械的特点,在出现质量问题时,各方责任也较难确定。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械是医疗机构与生产企业共同完成设计制作的,其中包含对患者病损的测量以及医疗器械的设计、生产、使用等多个环节,任何一个环节出现问题,都有可能导致定制式医疗器械无法达到预期效果,甚至对患者产生伤害。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械在使用中一旦出现问题,在监管中很难确定究竟是生产企业的原因还是医疗机构的原因,很难确定问题究竟出现在测量环节、设计环节、生产环节还是使用环节。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><img class="" data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcQfBWeOeL6EQotISletOpQuabyiaeE0qBK1Y9EI6ibCpQVoiaz3uia5nR88k0Oz4bZJChf8aDRU4QHnA/640?wx_fmt=png" data-type="png" data-w="653" style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 10px;margin-right: auto;margin-left: auto;display: block;" /></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-weight: 700;border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">备案仍需严管</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">我国对定制式医疗器械实行备案管理,《定制式医疗器械监督管理规定(试行)》规定:</span><span style="font-size: 15px;color: rgb(17, 15, 15);">“医疗器械生产企业及医疗机构共同作为定制式医疗器械备案人,在生产、使用定制式医疗器械前应当向医疗器械生产企业所在地(进口产品为代理人所在地)省、自治区、直辖市药品监督管理部门备案。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">”由此可见,相较于部分非定制式医疗器械,对于定制式医疗器械上市前的监管有适当放松,这既是适应临床治疗的需要,又是简政放权、激发市场活力、释放社会创造力的需要。</span><span style="border-width: 0px;border-style: initial;border-color: initial;font-size: 15px;color: rgb(17, 15, 15);">但适当放松上市前监管并不代表没有监管,监管部门对于定制式医疗器械的上市后监管并未放松。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">上市后监管如生产质量管理体系、医疗器械标签说明书、不良事件监测、产品可追溯性等要求,对定制式医疗器械仍然是适用的。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">所以,监管部门对于定制式医疗器械生产企业的质量管理体系、生产企业与医疗机构数据传递记录、生产批记录以及产品的放行程序、条件和批准要求、质量控制、标签和说明书等都应当予以重点关注。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">在使用环节,监管部门应当对医疗机构与生产企业之间数据传递、产品验收、购进记录、医疗器械的标签说明书、医疗器械购进发票、使用记录、可追溯性、不良事件监测等内容予以重点关注。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">严管定制式医疗器械生产、使用单位资质。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">虽然定制式医疗器械上市前只需备案,但是监管部门对相关生产企业的资质、医疗机构的资质有着严格的要求。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械生产企业必须具有相同类型的依据标准规格批量生产的医疗器械注册证及相应生产许可证(境外生产企业应当持有注册地或者生产地址所在国家或者地区医疗器械主管部门出具的企业资格证明文件)。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">同时,生产企业还应当具备相同类型的依据标准规格批量生产的医疗器械的生产能力和生产经验,并符合相应的质量管理体系要求,有定制式医疗器械研制、生产所需的专业技术人员,具备定制式医疗器械研制能力和研究基础。</span><span style="font-size: 15px;color: rgb(17, 15, 15);">另外,定制式医疗器械是不允许委托生产的。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">定制式医疗器械使用单位应当是三级综合或者三级专科医院,具有与使用的定制式医疗器械相适应的诊疗项目;</span><span style="font-size: 15px;color: rgb(17, 15, 15);">有在医疗机构注册的、能够使用定制式医疗器械的医师;</span><span style="font-size: 15px;color: rgb(17, 15, 15);">具备使用同类已上市产品的经验,已开展同种疾病的研究和治疗,且临床专业水平在国内领先;</span><span style="font-size: 15px;color: rgb(17, 15, 15);">具备较高的医疗器械管理水平,已建立完善的医疗器械使用质量管理体系,具备医疗器械使用评价和医疗器械不良事件监测能力。</span></p><p style="border-width: 0px;border-style: initial;border-color: initial;margin-top: 0.63em;margin-bottom: 1.8em;font-size: 16px;counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0;color: rgb(25, 25, 25);font-family: "PingFang SC", Arial, 微软雅黑, 宋体, simsun, sans-serif;text-align: left;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 15px;color: rgb(17, 15, 15);">此外,作为定制式医疗器械备案人的医疗器械生产企业及医疗机构,必须向所在地省、自治区、直辖市药品监督管理部门和卫生健康主管部门递交上一年度定制式医疗器械的生产和使用年度报告。</span></p><p><br /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 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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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;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;"><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;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:广州市天河区高塘路235号时代E-PARK7栋801、802室 </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;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="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;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="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;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="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;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="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;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://gb.parts-ultrasound.com/</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;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="white-space: normal;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);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;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="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;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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;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="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;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="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;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="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;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;">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;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><p><br /></p>
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