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双随机最狠?医疗器械三随机飞行检查已来!

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发表于 2020-10-19 23:48:57 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">?前不久,湖南省郴州市药监局首次开展医疗器械“双随机”飞行检查的消息,着实引发了业内不少人的关注。但是,比“双随机”还要多了一个随机的医械“三随机”飞行检查,也已经诞生了。&nbsp;</span></p><p><br  /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhveTfofdZuongyG32OupObEnuKPKXgg5OWweOe2uAxiaqE8GS1mLttcjwvHFBzRgPpKdXlJcrDmEk0w/0?wx_fmt=jpeg" data-ratio="0.7959183673469388" data-w="490"  /></p><p style="text-align:center"><br  /></p><p><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??何谓“双随机”飞检?&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??顾名思义,“双随即”抽查+飞行检查的方式。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">?? “双随机”抽查机制指的是,随机抽取被检查对象、随机选派检查人员的抽查机制。这意味着每个市场主体的头上都悬着一把“达摩克利斯之剑”,都可能被抽取到;同时,执法人员只能阳光行政,不能再‘看谁不顺眼’就去检查,即用制度限制监管部门的自由裁量权。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??2015年7月22日,国务院常务会议决定推广随机抽查机制,李克强总理指出,建立“双随机”抽查机制,是加强事中事后监管的一项重大改革。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??而飞行检查是事先不通知被抽查单位和监管当事人的一种检查方式,将“双随机”抽查机制引入飞行检查,意味着更为平等、阳光、严格的医疗器械监管。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??比如,湖南省郴州市药监局的做法是:采用随机抽查的方式从医疗器械检查员库中抽取12名检查执法人员,分4个检查组对全市11个县(市、区)的医疗器械经营和使用单位进行为期5天的飞行检查;检查对象也是通过电脑随机抽查的方式确定,每个县(市、区)抽取3家医疗器械经营企业和1家二级以上医疗机构,抽查结果当场密封,等到检查开始再启封。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??昆明展开“三随机”飞检!&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??据云南信息报消息,为了贯彻落实国家总局《药品医疗器械飞行检查办法》的相关要求,进一步强化事中事后监管,昆明市药局制定了《2016年度医疗器械经营环节飞行检查工作方案》,并“三随机”开展医疗器械经营环节飞行检查。&nbsp;</span></p><p><br  /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhveTfofdZuongyG32OupObEnqQCTH6NzDwNj20A0dV1MWachibwS4Rax9ce73MHXpia1mJ1HiccTVJwFA/0?wx_fmt=jpeg" data-ratio="0.7971014492753623" data-w="276"  /></p><p style="text-align:center"><br  /></p><p><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??昆明市药监局的“三随机”飞检,即随机抽取被检查企业、随机安排检查时间、随机选派执法人员,在“双随机”之上多了一个随机安排检查时间,确保执法人员能在第一时间进入检查现场,直接针对可能存在的问题开展检查,能及时发现违法行为并严厉打击,促进阳光监督和公平执法。&nbsp;</span><br style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px; white-space: normal;"  /><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;">??从“双随机”到“三随机”,还都先应用到医疗器械经营企业身上,说明药监部门对械商的监管正在加强,而监管方式的创新也一直在路上。</span><br  /></p><p><span style="color: rgb(51, 51, 51); font-family: &#39;Microsoft YaHei&#39;, 宋体, Arial; line-height: 32px; text-indent: 30px;"><br  /></span></p><p><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; 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line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></p><p style="max-width: 100%; min-height: 1em; 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; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询:QQ: &nbsp;712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; 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