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<p style="white-space: normal;text-align: center;"><img class="rich_pages js_insertlocalimg" data-backh="253" data-backw="578" data-ratio="0.43859649122807015" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_gif/dx3KibwtDhvd30KriaSbvhoncZUg9ZbETjscR1rN5dSCfznIuBFJJWmiauFOFKJq6LKLDom0CYRBzWtBO9Qp0jHhw/640?wx_fmt=gif" data-type="gif" data-w="798" style="width: 100%;height: auto;" /></p><section style="font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;line-height: 27.2px;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section powered-by="gulangu" style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section powered-by="gulangu"><section powered-by="gulangu"><p><span style="font-size: 15px;color: rgb(178, 178, 178);">来源：赛柏蓝器械</span></p><p><span style="font-size: 15px;color: rgb(178, 178, 178);">编辑：米克</span></p><section 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;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;border-width: 1px;border-style: dashed;border-color: rgb(0, 85, 191);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="padding: 5px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;background-color: rgb(249, 248, 248);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="padding: 1em;max-width: 100%;letter-spacing: 1.5px;line-height: 1.75em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">不合格的产品将全程追溯</span></strong></p></section></section></section></section></section></section><section 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;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 20px auto;max-width: 100%;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;background-image: url("http://mmbiz.qpic.cn/mmbiz_png/oMlX8Lll9Jj6ibwA0TErBVyMTJC45iaXeG7B1MJnlH24KNrMFtiaNLIHFrtBLDWqTAUmetHJdPTYa6kjia3FK1JyMw/640?wx_fmt=png");background-size: 100%;background-position: center bottom;background-repeat: no-repeat;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="padding: 20px 1.8em 13px;max-width: 100%;display: flex;justify-content: center;align-items: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;width: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><img class="__bg_gif" data-ratio="0.6666666666666666" data-type="gif" data-w="300" src="http://mmbiz.qpic.cn/mmbiz_gif/rrMc1yuOwNzw89L9m0uPhJHyHBZT9xnKOXTABXnq1NP5zYW34sUlT8My4nPdZXjAAlflI7HWc6P2Jco0iaWFomQ/640?wx_fmt=gif" style="box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 32px !important;" /></section><section style="margin-top: 5px;max-width: 100%;display: inline-block;color: rgb(0, 129, 204);font-size: 18px;box-sizing: border-box !important;overflow-wrap: break-word !important;">NO.1</section></section></section></section></section></section><p style="max-width: 100%;min-height: 1em;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);text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;overflow-wrap: break-word !important;">抽检械企产品是否合格</span></strong><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p style="max-width: 100%;min-height: 1em;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);box-sizing: border-box !important;overflow-wrap: break-word !important;"><br /></p><p><span style="font-size: 15px;">6月3日，国家药监局召开疫情防控医疗器械监督抽检视频调度会议，进一步贯彻落实市场监管总局等七部委《全国防疫物资产品质量和市场秩序专项整治行动方案》，并释放重要信息，具体来看：</span></p><p style="margin-top: 10px;margin-bottom: 10px;"><img class="rich_pages" data-ratio="0.2948073701842546" data-s="300,640" data-type="png" data-w="1194" src="http://mmbiz.qpic.cn/mmbiz_png/9BMUTzRcwdS9UAiahY36qZBOIFziaKS9HIsNaicl266HZc7K2Avs429r0xAnARibaHR0lNXwQNN5IzpMHib4AKgibOKQ/640?wx_fmt=png" style="box-sizing: border-box !important;overflow-wrap: break-word !important;width: 100%;visibility: visible !important;height: auto;" data-backw="578" data-backh="170" /></p><p><span style="font-size: 15px;">会议强调，各级药品监管部门要利用监督抽检手段，以检验发现问题倒逼企业落实质量管理。</span><span style="color: rgb(0, 0, 0);font-size: 15px;">要按照国家局的要求，推进医疗器械监督抽检工作，强化对新型冠状病毒检测试剂、呼吸机、医用防护服、医用口罩、额温枪等疫情防控医疗器械的抽查检验。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">会议指出，</span><span style="font-size: 15px;color: rgb(0, 0, 0);">要突出高风险产品抽检，加大对新批准企业、新注册产品、以及日常监管中发现风险信号的产品的监督抽检力度</span><span style="font-size: 15px;">，确保相关企业产品质量。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">日前，市场监管总局、国家发展改革委、工业和信息化部、公安部、商务部、海关总署、药监局联合印发《全国防疫物资产品质量和市场秩序专项整治行动方案》的通知，要求全国各地区相关部门开展整治行动。<br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></span></p><p><br /></p><p style="margin-top: 10px;margin-bottom: 10px;"><img class="rich_pages" data-ratio="0.29553264604810997" data-s="300,640" data-type="png" data-w="1164" src="http://mmbiz.qpic.cn/mmbiz_png/9BMUTzRcwdS9UAiahY36qZBOIFziaKS9HICRJYz3icPCv1l8TvpkGFTRwI3ZOsnIXGyIUiag6FKnEjYXNdpQh2NeHg/640?wx_fmt=png" style="box-sizing: border-box !important;overflow-wrap: break-word !important;width: 100%;visibility: visible !important;height: auto;" data-backw="578" data-backh="171" /></p><p><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">整治是全过程的，将贯穿防疫物资生产、流通、消费、出口全链条监管。将检查生产源头、企业资质、产品标准、产品质量。</span></strong></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">同时，</span><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">对不合格产品将全流程追溯</span></strong><span style="font-size: 15px;">，依法追究生产经营者责任，严查出口防疫物资质量。</span></p><section 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;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 20px auto;max-width: 100%;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;background-image: url("http://mmbiz.qpic.cn/mmbiz_png/oMlX8Lll9Jj6ibwA0TErBVyMTJC45iaXeG7B1MJnlH24KNrMFtiaNLIHFrtBLDWqTAUmetHJdPTYa6kjia3FK1JyMw/640?wx_fmt=png");background-size: 100%;background-position: center bottom;background-repeat: no-repeat;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="padding: 20px 1.8em 13px;max-width: 100%;display: flex;justify-content: center;align-items: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;width: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><img class="__bg_gif" data-ratio="0.6666666666666666" data-type="gif" data-w="300" src="http://mmbiz.qpic.cn/mmbiz_gif/rrMc1yuOwNzw89L9m0uPhJHyHBZT9xnKOXTABXnq1NP5zYW34sUlT8My4nPdZXjAAlflI7HWc6P2Jco0iaWFomQ/640?wx_fmt=gif" style="box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 32px !important;" /></section><section style="margin-top: 5px;max-width: 100%;display: inline-block;color: rgb(0, 129, 204);font-size: 18px;box-sizing: border-box !important;overflow-wrap: break-word !important;">NO.2</section></section></section></section></section></section><p style="max-width: 100%;min-height: 1em;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);text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">国家医疗器械检查员名单公布</span></strong></span></p><p style="max-width: 100%;min-height: 1em;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);box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">6月3日，国家局食品药品审核查验中心发布第5批《国家医疗器械检查员名单》，截止目前5批器械检查员共230人。各地也纷纷响应，成立专业检查组。</span></p><p style="margin-top: 10px;margin-bottom: 10px;"><img class="rich_pages" data-ratio="0.40134907251264756" data-s="300,640" data-type="png" data-w="1186" src="http://mmbiz.qpic.cn/mmbiz_png/9BMUTzRcwdS9UAiahY36qZBOIFziaKS9HIzUibJGticoHuP7DELt6FWtppIrhEK5F9lygnbEv4W5CnZicWSOG3Ic9Zg/640?wx_fmt=png" style="box-sizing: border-box !important;overflow-wrap: break-word !important;width: 100%;visibility: visible !important;height: auto;" data-backw="578" data-backh="232" /></p><p><span style="font-size: 15px;">5月21日，广东药监局公布部分检查员考核合格消息，</span><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">目前多省已经成立职业化医疗器械检查队伍</span></strong><span style="font-size: 15px;">，江西、陕西、河北、山东、浙江、上海等等。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><h2><span style="font-size: 15px;">这意味着，在医疗器械检查中，最专业的检查员要来了，国务院此前发布《关于建立职业化专业化药品药品检查员队伍的意见》。</span></h2><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">文件强调，</span><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">职业化专业化医疗器械检查员是指经药品监管部门认定，依法对管理相对人从事药品研制、生产等场所、活动进行合规确认和风险研判的人员。</span></strong></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">具体来看，国务院监管部门主要医疗器械研发过程现场检查，会从医疗器械临床试验质量管理规范执行情况合规性检查。承担医疗器械境外现场检查以及生产环节重大有因检查。</span></p><p><span style="font-size: 15px;"> </span></p><p><span style="font-size: 15px;">而省级药品监管部门主要医疗器械生产过程的现场检查，以及有关生产质量管理规范执行情况合规性检查。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">省级部门还将对医疗器械批发企业、零售连锁总部、互联网销售第三方平台也将进行相关现场检查。</span><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">可以看出国家针对医疗器械领域的各个环节，各个渠道都做了部署。</span></strong></p><section 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;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 20px auto;max-width: 100%;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;display: inline-block;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;background-image: url("http://mmbiz.qpic.cn/mmbiz_png/oMlX8Lll9Jj6ibwA0TErBVyMTJC45iaXeG7B1MJnlH24KNrMFtiaNLIHFrtBLDWqTAUmetHJdPTYa6kjia3FK1JyMw/640?wx_fmt=png");background-size: 100%;background-position: center bottom;background-repeat: no-repeat;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="padding: 20px 1.8em 13px;max-width: 100%;display: flex;justify-content: center;align-items: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="max-width: 100%;width: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><img class="__bg_gif" data-ratio="0.6666666666666666" data-type="gif" data-w="300" src="http://mmbiz.qpic.cn/mmbiz_gif/rrMc1yuOwNzw89L9m0uPhJHyHBZT9xnKOXTABXnq1NP5zYW34sUlT8My4nPdZXjAAlflI7HWc6P2Jco0iaWFomQ/640?wx_fmt=gif" style="box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 32px !important;" /></section><section style="margin-top: 5px;max-width: 100%;display: inline-block;color: rgb(0, 129, 204);font-size: 18px;box-sizing: border-box !important;overflow-wrap: break-word !important;">NO.3</section></section></section></section></section></section><p style="max-width: 100%;min-height: 1em;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);text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;color: rgb(2, 30, 170);box-sizing: border-box !important;overflow-wrap: break-word !important;">整治医疗器械经销商</span></strong></p><p style="max-width: 100%;min-height: 1em;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);box-sizing: border-box !important;overflow-wrap: break-word !important;"><br /></p><p><span style="font-size: 15px;">在《全国防疫物资产品质量和市场秩序专项整治行动方案》通知指出，将全面加强出口防疫物资监管。严把五类防疫物资出口质量关，加大出口防疫物资查验力度。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">对不符合相关质量标准的出口产品，要追溯经销商、生产企业以及认证检验检测、价格收费各个环节。</span></strong></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">对投诉举报较多的出口企业进行全面核查，对抽检不合格，存在产品质量安全重大问题的，依法从严查处。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="color: rgb(0, 92, 173);"><strong><span style="color: rgb(0, 92, 173);font-size: 15px;">对于认证检验检测方面，通知指出，将充分发挥认证检验检测机构在质量监管中的重要作用，明确并公布从事国内认证和主要国际辖区认证业务的机构名单。</span></strong></span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">严厉打击伪造、冒用、非法买卖认证证书和认证标志，未经批准擅自在我国境内从事认证、检验检测活动的违法行为。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">将打击生产销售和出口不符合相关标准的产品，</span><strong><span style="font-size: 15px;color: rgb(0, 92, 173);">在产品中掺杂掺假、以假充真、以次充好或者以不合格产品冒充合格产品</span></strong><span style="font-size: 15px;">，生产销售过期失效产品，生产销售无生产日期、无厂名厂址、无产品质量合格证明等“三无”产品等质量违法行为。</span></p><p><br style="max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;" /></p><p><span style="font-size: 15px;">时间上，通知指出，</span><span style="font-size: 15px;color: rgb(0, 92, 173);"><strong>在5月中下旬，市场监管总局会同有关部门开展全国专项整治行动督导，6月底进行全面工作总结。</strong></span></p><p><br /></p></section></section></section></section></section><p style="font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;letter-spacing: 0.544px;widows: 1;font-size: 16px;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;font-size: 12px;box-sizing: border-box !important;overflow-wrap: break-word 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发表于 2020-10-19 22:39:21