新型冠状病毒肺炎防疫或捐赠物资采购标准公告

admin

                    

                    

                    
                    
                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/26c1bcb484936f4aaf17c24d47f3a105_2.png" /></p></p><p><br  /></p><section><span>近期，国内外社会各界踊跃提出采购、捐赠防疫医用耗材的意愿，为便于识别采购、捐赠耗材能否作为医用，实现及时有效采购捐赠，根据近日大量咨询情况，现就采购或捐赠防疫医用耗材有关标准（详见附件）和事项公告如下：</span></section><section><br  /></section><section><span>一、境内医疗器械生产企业产品</span></section><p><br  /></p><section><span>（一）在境内取得医疗器械注册证和医疗器械生产许可证的，可以采购或捐赠；</span></section><p><br  /></p><section><span>（二）生产供应出口医用耗材，但未在境内取得医疗器械注册证和医疗器械生产许可证的，由武汉市市场监督管理局将企业提供的性能指标、微生物指标等提交至湖北省药品监督管理局与国内标准进行一致性比对评价，比对通过的，可以采购或捐赠。</span></section><section><br  /></section><section><span>二、境外医疗器械生产企业产品</span></section><section><span>（一）在境内取得进口医疗器械产品注册证等资质的，可以采购或捐赠；</span></section><p><br  /></p><section><span>（二）未在境内取得进口医疗器械产品注册证，符合附件中“国外标准”任何一个，相关产品可以提供境外医疗器械上市证明文件和检验报告的，可以采购或捐赠，到货后直接发往医疗机构使用；</span></section><p><br  /></p><section><span>（三）未在境内取得进口医疗器械产品注册证，符合附件中“国外标准”任何一个，但相关产品无法提供境外医疗器械上市证明文件和检验报告的，由武汉市新型肺炎防控指挥部应急保障组到货物现场查验，必要时抽样送检验机构对关键指标进行检验，符合要求的，发往医疗机构使用。</span></section><section><br  /></section><section><span>不符合以上情形的，无论是采购还是捐赠的物资，均不得作为医用。</span><span>确有特殊需要的，由武汉市市场监督管理局将产品送有资质的检验机构按附件中“国内标准”检验合格后方可使用。</span></section><p><br  /></p><section><span>本公告是为疫情防控制定的紧急措施，疫情结束后自行废止。</span></section><section><br  /></section><section><span>境内产品标准比对联系人：</span><br  /><span>黄章红18971110315&nbsp;&nbsp;叶道松18971111653</span></section><section><br  /></section><section><span>境外产品标准比对联系人：</span></section><section><span>唐&nbsp; 舟18971112686</span></section><section><br  /></section><section><span>附件：</span><span>防疫医用耗材国内标准及国外标准对照表</span></section><section><span><br  /></span></section><p><span>（点击图片可放大浏览）</span></p><p><p><img src="image/20201014/d51e7f63c7052354ea77f64641d2044f_3.png" /></p></p><p><span><strong><span>武汉市新型肺炎防控指挥部应急保障组</span></strong></span></p><p><span><strong><span>2020年1月29日</span></strong></span></p><p><br  /></p><p><span>奥咨达整理编辑</span><br  /></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#27939d"><p><a data-miniprogram-appid="wxdc7efe409d688f37" data-miniprogram-path="pages/index/index" data-miniprogram-nickname="智械采购" href="" data-miniprogram-type="image" data-miniprogram-servicetype="" href=""><p><img src="image/20201014/8edb31f87313bf5aa17544207dad3968_4.gif" /></p></a></p><p><br  /></p></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_5.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652972172&amp;idx=1&amp;sn=a9acc8951f8e3449640d8e7ad1fa9b1e&amp;chksm=843f461bb348cf0d595532e14e0d7bb80131eb9f204c006c805ca8a5b745fd640c3f7b506eac&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"></a></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652972185&amp;idx=1&amp;sn=40ecc918985ef8ae6a8606763d374466&amp;chksm=843f460eb348cf1832d68d9239bbf9328b5271de807a4df6df60120edb47089fdb4c2fe8f146&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>疫区“救命神器”生产流程！</span><span>（附自制口罩制作方法）</span></a><br  /></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652972185&amp;idx=2&amp;sn=f8be0cd0b7e5cf02d86a5be39ccf75cd&amp;chksm=843f460eb348cf18fe9fe543d4d189c17ca44e8d67b70a90b8a207b1bef4a33de8946adca23a&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>上海电气向武汉疫情防控一线捐赠2475万元CT设备</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><br  /></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652972172&amp;idx=1&amp;sn=a9acc8951f8e3449640d8e7ad1fa9b1e&amp;chksm=843f461bb348cf0d595532e14e0d7bb80131eb9f204c006c805ca8a5b745fd640c3f7b506eac&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>5例确诊/疑似新型冠状病毒感染的胸部CT</span></a><br  /></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652972165&amp;idx=1&amp;sn=d87cbb68095122e8f03b980931962e63&amp;chksm=843f4612b348cf041d7e70dd2dc0bfb7995247255c72efbc5e6d4df599e48803a5df1017c743&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>新型冠状病毒感染肺炎正确预防方法！</span></a></section></section></section></section></section></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/aad9f56b0707b5374bbac6273a663447_6.jpg" /></p></p>