资阳市市场监管局全面做好新《第一类医疗器械产品目录》实施工作
<!----><style type="text/css">html{font-size:375%}</style><link href="https://pic.app.jiuquhe.com/static/publish/css/style.css?v=1605251010487" rel="stylesheet" position="1" data-qf-origin="/static/publish/css/style.css?v=1605251010487"><div class="preview_article "> <!----> <p class="s5"><span class="s2"><span class="bumpedFont15">（</span></span><span class="s2"><span class="bumpedFont15">1</span></span><span class="s2"><span class="bumpedFont15">）积极部署，明确工作重点</span></span><span class="s2"><span class="bumpedFont15">。</span></span><span class="s3"><span class="bumpedFont15">制发</span></span><span class="s3"><span class="bumpedFont15">了</span></span><span class="s3"><span class="bumpedFont15">《关于做好</span></span><span class="s3"><span class="bumpedFont15"><</span></span><span class="s3"><span class="bumpedFont15">第一类医疗器械产品目录</span></span><span class="s3"><span class="bumpedFont15">></span></span><span class="s3"><span class="bumpedFont15">实施相关工作的通知》，对</span></span><span class="s3"><span class="bumpedFont15">全</span></span><span class="s3"><span class="bumpedFont15">市</span></span><span class="s3"><span class="bumpedFont15">新《目录》</span></span><span class="s3"><span class="bumpedFont15">实施</span></span><span class="s3"><span class="bumpedFont15">和</span></span><span class="s3"><span class="bumpedFont15">备案清理规范工作</span></span><span class="s3"><span class="bumpedFont15">的目标、要求、实施步骤和责任人</span></span><span class="s3"><span class="bumpedFont15">进行</span></span><span class="s3"><span class="bumpedFont15">系统</span></span><span class="s3"><span class="bumpedFont15">安排</span></span><span class="s3"><span class="bumpedFont15">，明确以</span></span><span class="s4"><span class="bumpedFont15">医用冷敷贴等物理降温设备和液体、膏状敷料</span></span><span class="s4"><span class="bumpedFont15">等为</span></span><span class="s3"><span class="bumpedFont15">清理重点。</span></span></p><p class="s5"> </p><p class="s5"><span class="s2"><span class="bumpedFont15">（</span></span><span class="s2"><span class="bumpedFont15">2</span></span><span class="s2"><span class="bumpedFont15">）全面清查，规范备案管理。</span></span><span class="s3"><span class="bumpedFont15">逐一走访相关企业，加大政策法规宣传。全覆盖比对核实已备案信息，对部分需要按新《目录》进行进</span></span><span class="s4"><span class="bumpedFont15">一步完善的备案产品开展现场核查，指导备案人制定整改计划，并及时跟进企业整改进度</span></span><span class="s4"><span class="bumpedFont15">。</span></span></p><p class="s5"> </p><p class="s5"><span class="s2"><span class="bumpedFont15">（</span></span><span class="s2"><span class="bumpedFont15">3</span></span><span class="s2"><span class="bumpedFont15">）强化监督</span></span><span class="s2"><span class="bumpedFont15">，确保</span></span><span class="s2"><span class="bumpedFont15">企业依法经营</span></span><span class="s2"><span class="bumpedFont15">。</span></span><span class="s4"><span class="bumpedFont15">在</span></span><span class="s4"><span class="bumpedFont15">加强事前指导</span></span><span class="s4"><span class="bumpedFont15">、提升备案工作质量基础上，</span></span><span class="s4"><span class="bumpedFont15">严格执行第一类医疗器械生产企业备案后现场检查的</span></span><span class="s4"><span class="bumpedFont15">要求，加强事后监督，</span></span><span class="s4"><span class="bumpedFont15">严防</span></span><span class="s4"><span class="bumpedFont15">违法</span></span><span class="s4"><span class="bumpedFont15">违规行为发</span></span><span class="s4"><span class="bumpedFont15">生。</span></span></p><p class="s5"> </p><p class="s6"><span class="s4"><span class="bumpedFont15">截至</span></span><span class="s4"><span class="bumpedFont15">4月1日，</span></span><span class="s4"><span class="bumpedFont15">我市已对</span></span><span class="s4"><span class="bumpedFont15">16家第一类医疗器械生产企业</span></span><span class="s4"><span class="bumpedFont15">备案</span></span><span class="s4"><span class="bumpedFont15">的</span></span><span class="s4"><span class="bumpedFont15">93个</span></span><span class="s4"><span class="bumpedFont15">产品进行了清查，</span></span><span class="s4"><span class="bumpedFont15">取消</span></span><span class="s4"><span class="bumpedFont15">备案</span></span><span class="s4"><span class="bumpedFont15">20个（其中包括</span></span><span class="s4"><span class="bumpedFont15">医用冷敷贴等物理降温设备和液体、膏状敷料等</span></span><span class="s4"><span class="bumpedFont15">产品</span></span><span class="s4"><span class="bumpedFont15">9</span></span><span class="s4"><span class="bumpedFont15">个</span></span><span class="s4"><span class="bumpedFont15">），变更备案</span></span><span class="s4"><span class="bumpedFont15">29</span></span><span class="s4"><span class="bumpedFont15">个</span></span><span class="s4"><span class="bumpedFont15">。</span></span></p><p class="s6"> </p><p class="s6"><span class="s4"><span class="bumpedFont15">（本文由资阳市市场监管局提供，文/</span></span><span class="s4"><span class="bumpedFont15">刘陈</span></span><span class="s4"><span class="bumpedFont15">）</span></span></p> <!----></div> 谢谢分享 不错哦感谢告知 {:hemabaozhu:} 谢谢分享哦
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