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<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="letter-spacing: 0.544px;white-space: normal;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p style="text-align: start;"><span style="font-size: 15px;color: rgb(136, 136, 136);">来源:第三方维修平台</span></p><section class="" data-tools="gulangu" data-id="92990" data-color="#f5f5f4" data-custom="#f5f5f4" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-bgless="spin" data-bglessp="280" data-bgopacity="50%" data-width="100%" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="92990" data-color="#f5f5f4" data-custom="#f5f5f4" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-bgless="spin" data-bglessp="280" data-bgopacity="50%" data-width="100%" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-role="paragraph" class="" style="max-width: 100%;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", " ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;color: rgb(255, 255, 255);letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" data-original-title="" title="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span></strong></p><section class="" data-tools="gulangu" data-id="89429" style="max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;height: 50px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-right: auto;margin-left: auto;max-width: 100%;width: 48px;height: 48px;color: rgb(255, 255, 255);line-height: 48px;display: inline-block;background-image: url("http://mmbiz.qpic.cn/mmbiz_gif/bfCedyicff1XLognoh8szjPlH7YdelHlxLk7KqzJ0ic2B5JEzoElh5S50A9Xia9z0Fc4M2QibWadOrajOa1gl3PMBg/640?wx_fmt=gif");background-repeat: no-repeat;background-size: 100%;background-position: 0px center;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;font-weight: bold;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" data-original-title="" title="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span></p></section><section style="margin-top: -26px;max-width: 100%;height: 2px;background-color: rgb(34, 33, 33);box-sizing: border-box !important;word-wrap: break-word !important;"></section></section></section><section data-role="paragraph" class="" style="max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></p></section><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(255, 104, 39);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;">医疗设备第三方服务机构的地位已得到国家承认</strong></span></p></section><section class="" data-role="paragraph" style="max-width: 100%;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", " ingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">中国医疗设备独立服务机构(俗称第三方),作为医疗设备三方服务中的重要一方,在平抑我国医疗设备维保市场价格方面,一直起着不可或缺的重要作用。近些年,随着第三方公司的不断发展,更是弥补了厂商售后部门在服务我国广大医疗设备用户时响应的及时性、维修模式的多样性和地域覆盖的广阔性方面的不足。国家药监局也以正式文件的形式表达了对第三方服务群体的认可和支持,第三方在医疗设备维修服务中的作用和地位获得了国家层面的承认。</p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">2015年10月21日,国家食品药品监督管理总局公布第18号令《医疗器械使用质量监督管理办法》,此管理办法于2016年2月1日起施行,其中第十七条全文如下:</p><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-ratio="0.6900114810562572" data-s="300,640" data-type="png" data-w="871" src="http://mmbiz.qpic.cn/mmbiz_png/bfCedyicff1XLognoh8szjPlH7YdelHlx6DBAjo3PIdOYGV3I57W8RGWkoicgyVdQ7z9oZNBuPwvT7HREnFafNeQ/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 677px !important;" /></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械使用单位可以按照合同的约定要求医疗器械生产经营企业提供医疗器械维护维修服务,也<span style="max-width: 100%;color: rgb(0, 122, 170);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">可以委托有条件和能力的维修服务机构进行医疗器械维护维修</strong></span>,或者自行对在用医疗器械进行维护维修。</p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 122, 170);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械使用单位委托维修服务机构或者自行对在用医疗器械进行维护维修的,医疗器械生产经营企业应当按照合同的约定提供维护手册、维修手册、软件备份、故障代码表、备件清单、零部件、维修密码等维修必需的材料和信息。</strong></span></p><p style="max-width: 100%;min-height: 1em;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 data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="89429" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;height: 50px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-right: auto;margin-left: auto;max-width: 100%;width: 48px;height: 48px;color: rgb(255, 255, 255);line-height: 48px;display: inline-block;background-image: url("http://mmbiz.qpic.cn/mmbiz_gif/bfCedyicff1XLognoh8szjPlH7YdelHlxLk7KqzJ0ic2B5JEzoElh5S50A9Xia9z0Fc4M2QibWadOrajOa1gl3PMBg/640?wx_fmt=gif");background-repeat: no-repeat;background-size: 100%;background-position: 0px center;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;font-weight: bold;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;">2</span></p></section><section style="margin-top: -26px;max-width: 100%;height: 2px;background-color: rgb(34, 33, 33);box-sizing: border-box !important;word-wrap: break-word !important;"></section></section></section><section data-role="paragraph" class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(255, 104, 39);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">第三方公司现实生存环境恶劣,处于夹缝中生存</strong></span></p></section><section class="" data-role="paragraph" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">根据国家食药总局第18号令,医疗器械生产厂商应该向医疗器械使用单位以及有条件和能力的医疗器械服务机构(第三方公司)开放维修资料,包括维修密码和原厂零部件。但三年多过去,相关条例的执行情况却令人失望。</p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">由于缺乏政府部门监管,第三方公司也缺少向上反映的渠道,目前医疗器械生产厂家依然普遍拒绝或变相拒绝向第三方服务公司提供设备维修密码、设备零部件以及维修维护技术资料,导致上述条例形同虚设。厂家售后部门还不断利用自己的舆论优势误导设备用户和监管部门,更利用一些对第三方开展业务不利的法规条例,打击第三方竞争者,导致第三方服务公司生存环境非常艰难。</p><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-ratio="0.692063492063492" data-s="300,640" data-type="jpeg" data-w="630" src="http://mmbiz.qpic.cn/mmbiz_jpg/bfCedyicff1XLognoh8szjPlH7YdelHlxr6O2CDHeAtDiaXhjFALwc2icg8BolRWtmtlO1r8MHIOJISNYygUKUzGQ/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 630px !important;" /></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;">具体表现为:</p><p style="max-width: 100%;min-height: 1em;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 data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">1.获取维修密码依然存在障碍,甚至更加恶化。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">众所周知,二十年前所有厂商在售后维修上没有任何密码,但是随着发现售后有利可图,几乎所有设备生产厂商都对设备的检测维修程序设置密码锁,并且是会随时间变化的动态密码锁,如GE公司采用硬件动态密码狗,西门子则采用软件动态密码,PHILIPS公司连同查看资料文件都需要专门的密码,维修机器更加是密码层层相套,其主要目的就是为了阻止掌握维修技术的工程师参与维保竞争。目前厂家售后部门依然漠视第18号令的存在,拒绝向独立服务商提供维修密码,并有进一步增加密码复杂度的趋势。如西门子公司今年又开始了一轮密码升级,密码位数从原来的20位直接升至256位。</span></p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 556px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">2.厂家维修部门通过控制关键核心零配件,如CT/DSA设备使用过程中需要更换的球管,达到排斥第三方竞争者,进而独占售后服务市场的目的。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">厂家维修部门控制和阻扰第三方获得球管的常用手段有:</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">a)针对第三方平行进口球管没有产品合格证,利用《医疗器械监督管理条例》中提到需要产品合格证为理由,进行投诉、阻挠。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">b)设法获取第三方平行进口球管的序列号,通过内部对国外球管代理商施加压力,逼迫其撤回销售至中国的球管。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">c)球管虽然戴着二类医疗器械的帽子,本质属性却只是一种零部件,必须依赖整机才能发挥作用。GE、西门子、飞利浦的球管长期都是在国外生产,一般都随整机注册而不单独注册。针对这个情况,个别厂家售后部门便利用近些年在国内设立球管厂并对球管进行了单独注册的“优势”(如西门子公司422型、688型球管),对第三方从国外进口的同型号球管以无注册证为由进行举报、打压。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">d)对替代球管生产商(如无锡的万睿视和珠海瑞能公司)销售的球管找各种理由进行各种阻扰,不让性价比更高的替代球管(如GE某款球管市场价160万,而VAREX的替代球管只需60几万)进入市场。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">e)在第三方服务的客户需要球管时进行价格歧视。如西门子的零兆球管,厂家售后部门通过把平时118万可以出售给终端用户的球管,提价至148万卖给第三方的保修客户,使得第三方在服务中完全丧失竞争优势,达到独家垄断售后市场的目的。</span></p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-cropselx1="0" data-cropselx2="556" data-cropsely1="0" data-cropsely2="357" data-ratio="0.88515625" data-s="300,640" data-type="jpeg" data-w="1280" src="http://mmbiz.qpic.cn/mmbiz_jpg/bfCedyicff1XLognoh8szjPlH7YdelHlx5sBUztNEibb3n3rutWWicibeibAq5HPre05kXhjn9u7kBe495x53gZOGibw/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 556px !important;" /></p><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label=" owered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 556px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">3.为了保护垄断利润,生产厂商售后部门还利用其他手段打压第三方公司。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">如:</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">a) 尽管国家已发文明确了第三方服务商群体的市场地位,但厂家售后部门依然向用户宣传自己是维保服务和零配件唯一合法来源,误导用户和招标公司在招标条件中提出单一来源采购、或“需要厂家授权”等条款,以达到屏蔽第三方服务公司参标的目的。</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">b) 罔顾第三方群体有众多优秀服务公司的事实,刻意收集个别第三方服务公司的一些不良问题,汇集成册,利用自己的市场优势地位进行宣传,制造舆论抹黑整个第三方群体,误导用户和国家有关部门。</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">c) 进一步加强零配件控制,个别设备厂商甚至开始在线路板上内置独立编号,通过软件控制让完全同型号的配件也无法使用,以达到垄断售后市场的目的。</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;"> </span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">厂家维修部门的上述行为,完全无视和违背了国家第18号令希望有一个适当竞争、均衡和谐,有利于终端用户的维修服务市场的精神,应尽快得到批评和纠正。</span></p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label="Powered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="89429" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;height: 50px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-right: auto;margin-left: auto;max-width: 100%;width: 48px;height: 48px;color: rgb(255, 255, 255);line-height: 48px;display: inline-block;background-image: url("http://mmbiz.qpic.cn/mmbiz_gif/bfCedyicff1XLognoh8szjPlH7YdelHlxLk7KqzJ0ic2B5JEzoElh5S50A9Xia9z0Fc4M2QibWadOrajOa1gl3PMBg/640?wx_fmt=gif");background-repeat: no-repeat;background-size: 100%;background-position: 0px center;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;font-weight: bold;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" data-original-title="" title="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">3</span></p></section><section style="margin-top: -26px;max-width: 100%;height: 2px;background-color: rgb(34, 33, 33);box-sizing: border-box !important;word-wrap: break-word !important;"></section></section></section><section data-role="paragraph" class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(255, 104, 39);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;">改善措施</strong></span></p></section><section class="" data-role="paragraph" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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: left;box-sizing: border-box !important;word-wrap: break-word !important;">为争取公平公正的生存环境,第三方群体需要去做的几件事情:</p><p style="max-width: 100%;min-height: 1em;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 data-role="outer" label="Powered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">1.成立自己的组织,集体发声。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">对于任何群体来说,无组织便无力量。第三方想要改变目前被压迫的生存环境,必须首先改变长期松散,各自为战的局面,树立团结意识、组织意识。在这方面,美国第三方群体的成功做法是值得借鉴的。26年前的美国第三方公司也同样正面临我国第三方现在的处境,1993年美国第三方公司抱团成立自己的行业组织IAMERS(国际医疗设备转售商和服务商协会),凝聚起了美国第三方群体的力量。IAMERS既是一个行业自律组织,又是美国第三方与美国FDA间沟通的管道。它代表第三方的合法利益,反映第三方公司的诉求,帮助政府相关部门了解行业真实情况,制定相关行业政策。从此监管机构只听厂家售后部门一面之词的历史结束了。 </span></p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-ratio="0.8662613981762918" data-s="300,640" data-type="png" data-w="658" src="http://mmbiz.qpic.cn/mmbiz_png/bfCedyicff1XLognoh8szjPlH7YdelHlxeqgYhRY3M3CLpqNCrhmTlIDBhyve46HKbTFLV5n1uia3jtAUoGJqJrA/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 658px !important;" /></p><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label="Powered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">2.树立法律意识,用法律武器维护自身权益。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">面对厂家售后部门设立专门的法律部门利用行业法规打击第三方的现实,第三方公司不能只钻研技术和业务,还必须学习研究相关的法律法规,懂法守法。同时,要加强斗争意识,牢记“以斗争求和平,则和平存;以妥协求和平,则和平亡”的教导,对拒不执行行业相关条令、甚至违反国家《反垄断法》,对第三方公司正常的业务行为进行污蔑和打击的厂家售后部门,在依法取证的前提下,勇于投诉和举报。</span></p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-ratio="0.6654545454545454" data-s="300,640" data-type="jpeg" data-w="550" src="http://mmbiz.qpic.cn/mmbiz_jpg/bfCedyicff1XLognoh8szjPlH7YdelHlxyboURs8HEWOS1nBDMb7easMrfy72VmYdrcTREX6UQq3qJjbGUVHLZA/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 550px !important;" /></p><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label="Powered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">3.相信政府,积极沟通,推动行业法规完善。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">国家有关部门为了营造一个健康有序的医疗设备市场发展环境,保障广大患者的利益,制定《医疗器械监督管理条例》和《医疗器械使用质量监督管理办法》,医疗器械售后服务也属于其管理范围。由于文字表意的局限性和现实情况的复杂性,难免出现对个别条文的解释存在歧义,或对某些特殊场景的适用性考虑不周的情况。这本来是一件很正常的事,问题是某些厂商维修部门恰恰利用了这些“漏洞”来回避对条例的执行,或打击竞争对手。</span></p><p style="max-width: 100%;min-height: 1em;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;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: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">例如1:</span></strong><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">《医疗器械使用质量监督管理办法》第十七条中的“按照合同的约定”就被厂家维修部门利用回避对条例的执行,使其完全形同虚设。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械使用单位可以</span><span style="max-width: 100%;font-size: 16px;color: rgb(0, 122, 170);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">按照合同的约定</strong></span><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">要求医疗器械生产经营企业提供医疗器械维护维修服务,也可以委托有条件和能力的维修服务机构进行医疗器械维护维修,或者自行对在用医疗器械进行维护维修。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械使用单位委托维修服务机构或者自行对在用医疗器械进行维护维修的,医疗器械生产经营企业应当</span><span style="max-width: 100%;font-size: 16px;color: rgb(0, 122, 170);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">按照合同的约定</strong></span><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">提供维护手册、维修手册、软件备份、故障代码表、备件清单、零部件、维修密码等维修必需的材料和信息。</span></p><p style="max-width: 100%;min-height: 1em;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;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: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">例如2:</span></strong><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">球管被归入医疗器械所带来的困扰。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">球管是CT、DSA和DR上需要经常更换的部件,由于被不合理的归入医疗器械(二类),受《医疗器械监督管理条例》制约,厂家维修部门也正是利用这一点打击第三方,已对第三方从事相关业务造成非常大的障碍。球管原本只是X射线类检查设备上的一个发出X射线部件,却被归入医疗器械(二类),是出于安全原因或是剂量精度的原因吗?那么放疗设备中的磁控管(射线发生器)的强度更烈,更应该算是医疗器械了!高压自动注射器中的推进马达的性能异常也有可能危及使用者的性命,磁共振产品的磁体和线圈也是成像的重要组成部分,是否也都应该归入医疗器械呢?</span></p><p style="max-width: 100%;min-height: 1em;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;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: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">例如3:</span></strong><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">西门子在德国本土生产的球管竟然不能在国内使用。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">根据《医疗器械注册管理办法》第二十八规定:</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 122, 170);box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">以整机注册的医疗器械,其医疗器械注册证书附表中的“产品性能结构及组成”栏内所列出的组合部件在不改变组合形式和预期用途的情况下单独销售的,可以免予单独注册。</span></strong></span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">由于整机部件可以免于注册,所以西门子在德国生产的球管均未在我国单独注册,第三方从德国平行进口球管使用也没有问题。但是,自从西门子在中国无锡也开厂生产同型号球管后,因为西门子无锡厂对所生产球管进行了单独注册,厂家售后部门居然误导地方药监执法部门说球管都是有注册证的,导致第三方从德国西门子原厂采购的球管遭地方药监查封,正常的维修工作无法进行。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">为防止国家的良好用意,沦为个别厂家售后部门谋求一己之利,打击竞争对手的工具。第三方应积极推动相关部门举行研讨会或听证会,研究行业条例中的模糊点,以及可能阻碍第三方售后服务发展的难点问题,帮助相关条文的明确</span>和完善。</p></section></section><section style="max-width: 100%;width: 1.2em;background: rgb(117, 117, 118);height: 6px;float: right;color: rgb(255, 255, 255);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 data-role="paragraph" class="" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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="rich_pages " data-copyright="0" data-ratio="0.75" data-s="300,640" data-type="jpeg" data-w="600" src="http://mmbiz.qpic.cn/mmbiz_jpg/bfCedyicff1XLognoh8szjPlH7YdelHlx0vKaZN0VdpLibicgostmoDRddHEFMEp4P9CvJys962dsMnqz3tFcow7g/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 600px !important;" /></p><p style="max-width: 100%;min-height: 1em;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></section><section data-role="outer" label="Powered by gulangu" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section class="" data-tools="gulangu" data-id="94817" data-color="#757576" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section data-width="100%" style="max-width: 100%;width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="padding-left: 6px;max-width: 100%;box-sizing: border-box;border-left: 6px solid rgb(117, 117, 118);word-wrap: break-word !important;"><section class="" data-brushtype="text" style="padding: 2px 12px;max-width: 100%;box-sizing: border-box;background: rgb(117, 117, 118);display: inline-block;letter-spacing: 1.5px;color: rgb(255, 255, 255);word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(242, 242, 242);font-family: 微软雅黑, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">4.“定标准、树榜样、广宣传”,用高品质的服务赢得社会尊重。</span></section></section><section style="padding-left: 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;border-bottom: 1px solid rgb(208, 208, 208);border-left: 1px solid rgb(208, 208, 208);border-top: none;border-right: none;word-wrap: break-word !important;"><section data-autoskip="1" class="" style="padding: 1em;max-width: 100%;box-sizing: border-box;font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">“方便快捷、价格低、服务有温度”是第三方公司的竞争优势所在,其中“价格低”是以往最吸引用户的一点。但需要注意的是,“低价竞争”是一把双刃剑,没有合理的利润就没有好的质量。另外时代也在变化,随着国家对医疗设备使用管理要求的提高,以及售后服务供给的增多,用户对服务的要求也在不断提高,没有质量的公司在未来将会失去一切。所以第三方公司必须与时俱进,建立“质量比低价更重要”的意识,提供合国家要求,得到广大医院用户的认可的高品质服务,这也是第三方群体当下是最关键、最根本的事。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">我国第三方群体数量众多,技术能力和服务水平良莠不齐,缺乏明确标准和规范,这种状况影响了广大设备用户以及国家相关部门对第三方群体的信心,对改善第三方群体的生存环境不利,组织制定第三方团体服务标准已成为当务之急。去年,中国医疗器械服务联盟CT分会,以设备生产商的技术服务手册为基础依据,汇聚联盟成员企业的亮点,结合我国的实际情况,编写完成了联盟企业《CT售后服务质量管理规范》</span><span style="max-width: 100%;font-size: 15px;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">(点击查看《重磅!首个由第三方服务商制定的《CT售后服务质量管理规范》出台!》)</span><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">。目前,其他大型设备的服务规范也正在组织编写完成中,期待能够早日出台。</span></p><p style="max-width: 100%;min-height: 1em;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;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">近些年随着来自第三方的竞争压力越来越大,某些厂家售后部门利用少数第三方公司服务中存在的不良问题,制造舆论抹黑第三方群体。尽管厂家售后部门有言论的自由、有批评的权利,我们也欢迎厂家的监督批评,但必须指出的是,对于个别公司的个别行为,如果借此攻击整个群体,则完全是以偏概全。面对厂家的舆论攻击,第三方的正确态度不是以牙还牙的攻击,而是把第三方群体中许多做得好的、值得尊敬的企业找出来,在全国范围广泛宣传,弘扬正气,让社会了解,供同行学习,在提升第三方群体服务水平的同时,也有利于第三方的生存环境的改善。如联盟成员企业杭州医维之星技术有限公司,针对CT服务市场“重维修,轻保养”的现状,对原有的保养流程</span><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;">(点击查看《</span><span style="max-width: 100%;font-size: 15px;color: rgb(0, 82, 255);box-sizing: border-box !important;word-wrap: break-word !important;">收藏!国内首个由第三方服务机构倾力打造的CT深度保养流程(含视频)</span><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;">》)</span><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">及工具进行了深化、细化,开发出了“CT深度保养”项目,受到业界广泛好评,用事实表明第三方服务公司是完全有能力在服务上超越厂家售后部门的。</span></p></section></section></section></section></section></section></section></section></section></section></section><p style="margin-right: 5px;margin-left: 5px;max-width: 100%;min-height: 1em;line-height: 1.75em;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></p><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></p></section></section></section></section></section></section></section></section></section></section></section></section><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: 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;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="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;text-align: left;"><img class="rich_pages" data-ratio="1" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcvQ5W66skZY3mYSqpoRYIMn3LOS0l9GkWVqSdiaw2RiclU8MiatfDmia3YvXxPRgDFiaZFibgUOEEfaYhA/640?wx_fmt=png" data-type="png" data-w="344" /></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;"><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="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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