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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="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;background-color: rgb(255, 255, 255);color: rgba(0, 0, 0, 0.298);font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p style="font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="display: block;color: rgb(0, 0, 0);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;background-color: rgb(255, 255, 255);font-size: 12px;">来源：医疗器械经销商联盟<br /></span></p><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><section data-tools="gulangu" data-id="88767" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="padding-bottom: 1.2em;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><section style="margin-top: -0.5em;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1em;height: 1em;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;font-size: 80px;line-height: 1em;color: rgb(31, 73, 125);word-wrap: break-word !important;">“</span><section style="margin-top: 1.6em;margin-left: -0.6em;max-width: 100%;box-sizing: border-box;width: 4em;border-bottom: 1px solid rgb(31, 73, 125);display: inline-block;vertical-align: middle;height: 1px;overflow: hidden;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></section></section><section style="margin-top: -0.5em;padding: 10px 2em;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="font-size: 14px;">抽检直接与信用挂钩，全国医疗器械大检查持续发力......</span></section><section style="max-width: 100%;box-sizing: border-box;display: inline-block;height: 1em;float: right;line-height: 1;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;width: 4em;border-bottom: 1px solid rgb(31, 73, 125);height: 1px;overflow: hidden;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></section><span style="margin-top: -0.11em;margin-left: -0.1em;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;font-size: 80px;color: rgb(31, 73, 125);word-wrap: break-word !important;">”</span></section></section></section></section><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 data-tools="gulangu" data-id="95326" 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-bottom: -15px;margin-left: -15px;max-width: 100%;width: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><img data-ratio="0.9473684210526315" data-type="gif" data-w="57" data-width="100%" src="http://mmbiz.qpic.cn/mmbiz_gif/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLaiaaHsYicBCW3etYXicJKu89ASc9MYLsGichyt5NvichA6Mib4Vp8zVcN5NA/640?wx_fmt=gif" class="__bg_gif" style="display: block;width: 32px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;" /></section><section data-brushtype="text" style="padding: 6px 1em;max-width: 100%;background: rgb(28, 37, 77);color: rgb(255, 255, 255);border-width: 3px;border-style: solid;border-color: rgb(254, 254, 254);transform: rotate(0deg);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;">国家药监局发布，最新版医疗器械质量检查管理办法出台</span></section></section></section></section><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">近日（3月13日），</span><span style="max-width: 100%;font-family: 黑体, SimHei;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">国家药品监督管理局</span><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">最新发布了《关于印发医疗器械质量抽查检验管理办法的通知》（以下简称《通知》）。</span></p><p style="max-width: 100%;min-height: 1em;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;"><img class="rich_pages" data-backh="175" data-backw="578" data-ratio="0.3025540275049116" data-s="300,640" data-type="png" data-w="1018" src="http://mmbiz.qpic.cn/mmbiz_png/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLwyQ0p3QibQjJlxicEVicK8CAUMuBwA4ibv9SndOAr8xpkEaicpcE0Z01Umw/640?wx_fmt=png" style="width: 677px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !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;"><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">《通知》称，为加强医疗器械监督管理，规范</span><span style="max-width: 100%;font-family: 黑体, SimHei;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械质量抽查检验</span><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">工作，国家药监局组织修订了《医疗器械质量抽查检验管理办法》。</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">值得注意的是，最新版《医疗器械质量抽查检验管理办法》发布后，原国家食品药品监督管理总局发布的《医疗器械质量监督抽查检验管理规定》（食药监械监〔2013〕212号）和《国家医疗器械抽查检验工作程序》（食药监办〔2014〕213号）同时废止。</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="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">换句话说，这<span style="max-width: 100%;">也是时隔6年后</span></span><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">国家药监局对于医疗器械行业监管标准的再次修订。</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-tools="gulangu" data-id="95326" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-bottom: -15px;margin-left: -15px;max-width: 100%;width: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><img data-ratio="0.9473684210526315" data-type="gif" data-w="57" data-width="100%" src="http://mmbiz.qpic.cn/mmbiz_gif/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLaiaaHsYicBCW3etYXicJKu89ASc9MYLsGichyt5NvichA6Mib4Vp8zVcN5NA/640?wx_fmt=gif" class="__bg_gif" style="display: block;width: 32px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;" /></section><section data-brushtype="text" style="padding: 6px 1em;max-width: 100%;background: rgb(28, 37, 77);color: rgb(255, 255, 255);border-width: 3px;border-style: solid;border-color: rgb(254, 254, 254);transform: rotate(0deg);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;">医疗器械行业监管持续发力，检查严格程度再次升级</span></section></section></section></section></section><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">首先，在监管部门职责中，《医疗器械质量抽查检验管理办法》规定，医疗器械质量抽检相关工作由各区域内的</span><span style="max-width: 100%;font-family: 黑体, SimHei;font-size: 14px;color: rgb(69, 67, 67);box-sizing: border-box !important;word-wrap: break-word !important;">省级和市级药品监管部门</span><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">负责。</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="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">而在对医疗器械企业义务的要求中，国家药监局是新增要求进口医疗器械注册人、备案人应当指定我国境内企业法人作为代理人，配合对进口医疗器械的抽查检验工作。</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="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">此外，值得注意的是，在医疗器械抽检的重点中，国家级抽检和省级抽检的标准也不尽相同。</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="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">在国家级<span style="font-size: 14px;max-width: 100%;">医疗器械抽检</span>过程中，以下医疗器械将作为重点:</span></p><p style="max-width: 100%;min-height: 1em;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;"><img class="rich_pages" data-ratio="0.43478260869565216" data-s="300,640" data-type="jpeg" data-w="437" src="http://mmbiz.qpic.cn/mmbiz_jpg/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLHOYPON1rqo2RsM2AV3IsGA2KzwphVvh6PcQJzdyqpwZsbJ1kgKJASw/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;width: 437px !important;visibility: visible !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;"><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">与国家级抽检的侧重点不同，省级医疗器械的抽检重点与国家医疗器械质量抽查互为补充</span><span style="font-size: 14px;max-width: 100%;font-family: 黑体, SimHei;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;"><br /></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-ratio="0.620137299771167" data-s="300,640" data-type="jpeg" data-w="437" src="http://mmbiz.qpic.cn/mmbiz_jpg/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLheJ7B2NnGvH3U5qv8RcAuhoEBjwpvEr3mT0ZOOBT5SicAzOlCiaN5IVQ/640?wx_fmt=jpeg" style="box-sizing: border-box !important;word-wrap: break-word !important;width: 437px !important;visibility: visible !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;"><span style="max-width: 100%;font-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">在抽检过程中，被抽样单位应主动提供的材料也做出了修订。最终确定为：</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（一）产品注册证复印件/备案凭证复印件；</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（二）经注册或者备案的产品技术要求；</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（三）生产经营使用有关记录； </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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（四）开展检验所需配套必需品。</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">与此同时，国家药监局还规定，医疗器械注册人、备案人和被抽样单位获知产品不符合规定后，应当履行以下义务：</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">（一）实施产品召回并发布召回信息；</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（二）立即深入进行自查，分析原因，进行风险评估；</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">（三）根据调查评估情况采取必要的风险控制措施。</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><section data-tools="gulangu" data-id="95326" 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;word-wrap: break-word !important;"><section style="margin-bottom: -15px;margin-left: -15px;max-width: 100%;width: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><img data-ratio="0.9473684210526315" data-type="gif" data-w="57" data-width="100%" src="http://mmbiz.qpic.cn/mmbiz_gif/YbTq6LNicqJ5IAx4z06J67yO10ib7YpWHLaiaaHsYicBCW3etYXicJKu89ASc9MYLsGichyt5NvichA6Mib4Vp8zVcN5NA/640?wx_fmt=gif" class="__bg_gif" style="display: block;width: 32px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;" /></section><section data-brushtype="text" style="padding: 6px 1em;max-width: 100%;background: rgb(28, 37, 77);color: rgb(255, 255, 255);border-width: 3px;border-style: solid;border-color: rgb(254, 254, 254);transform: rotate(0deg);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 14px;">医械行业大整治全面开启，国家级飞检+暗访+交叉检查将频发！</span></section></section></section></section><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="max-width: 100%;font-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">事实上，对比此前2019年8月末国家药监局所发布的《医疗器械质量抽查检验管理办法（征求意见稿）》中可以看出，《医疗器械质量抽查检验管理办法》最终做出了不少的删减，管理条例也由原本的51条修订为47条。</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="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">管理条例的颁布，意味着国家对于医疗器械行业的监管更加的全面和严格，专业化的流程下，医疗器械行业也会更加的规范。</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="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械企业拒绝抽检还将直接录入信用档案，增加监督检查频次。检查与信用直接挂钩，这也无疑加大了对于医疗器械企业的约束和惩治力度。</span></p></section><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">此外，本管理规定还表明，药品监督管理部门可以适时开展专项抽查检验，因监督检查、监测评价、稽查执法等工作需要开展抽样、检验的，不受抽样数量、地点、样品状态等限制，具体程序可参照本办法执行。</span></p></section><section 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;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">这也就意味着未来国家级的医疗器械检查将不局限于日常的检查，飞检、暗访以及交叉检查也将随机进行。在不打招呼的情况下进行突击检查，往往能检查出械企在日常生产运营过程中不易察觉的问题。</span></p></section><section data-role="paragraph" style="max-width: 100%;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;font-size: 16px;letter-spacing: 0.544px;white-space: normal;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;"><span style="font-size: 14px;color: rgb(69, 67, 67);max-width: 100%;font-family: 黑体, SimHei;box-sizing: border-box !important;word-wrap: break-word !important;">事实上，国家对于医疗器械企业的检查，其主要目的也是为了让医疗器械行业进行健康长久的发展，而企业跟行业更是休戚相关的。</span></p><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">因此，在“考验”尚未到来之前，企业首先应仔细研究国家颁布的相关法规，先行对自身进行彻底的检查整改。另外，械企还可以通过查看以往被查处企业所出现的问题，挖掘到自身可能存在的隐患问题，再加以进一步的自我检查。</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-family: 黑体, SimHei;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">总而言之，随着国家对于医疗器械行业监管力度的不断加强，未来械企的唯一道路只有合规合法经营。</span></p></section><p style="font-size: 16px;line-height: 24px;font-family: arial;white-space: normal;background-color: rgb(255, 255, 255);"><span style="display: block;font-size: 14px;"><br /><br /></span></p><p 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!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;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;text-indent: 0em;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">地址：广州市天河区高塘路235号时代E-PARK7栋801、802室 </span></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: 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12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">全国统一免费服务热线：400-020-6788</span></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 24.381px;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">公司官网：http://www.parts-ultrasound.com/</span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;text-indent: 0em;font-family: Arial, Verdana, sans-serif;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">微信公众帐号：</span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-size: 16px;text-align: left;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="rich_pages" data-ratio="1" data-s="300,640" data-type="png" data-w="344" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcvQ5W66skZY3mYSqpoRYIMn3LOS0l9GkWVqSdiaw2RiclU8MiatfDmia3YvXxPRgDFiaZFibgUOEEfaYhA/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 344px !important;" /></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">维修咨询：QQ: 712638 404</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">设备咨询: QQ: 712638 405</span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">交流Q群：1106 11074</span></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址：https://renchengyiliao.1688.com</span></p><p style="max-width: 100%;min-height: 1em;text-indent: 0em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">电子邮箱：sales@parts-ultrasound.com</span></p>
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发表于 2020-10-19 22:40:39