关于进口医疗器械注册申报资料试行电子签名有关事宜的通告

admin · 发表于 2020-10-14 10:16:54

                  <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></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><section data-role="paragraph"><section data-tplid="89781" data-tools="gulangu"><section data-tools="gulangu" data-id="95298"><section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><br  /></p><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><p><span>近期，已有部分境外申请人/注册人提交医疗器械注册申报资料时使用了电子签名。由于境外各国家（地区）对电子签名的法律规定不尽相同，为确保注册申报资料的法律效力，稳步开展审评工作，现就进口医疗器械注册申报资料试行电子签名有关事宜通知如下：</span></p><p><span><br  /></span></p><span>一、进口医疗器械注册申报资料中，涉及应由境外申请人/注册人签字的，可以是手写签名，也可以是电子签名，形式审查、立卷审查和技术审评过程中均予以认可。</span><p><span><br  /></span></p><span>二、进口医疗器械注册申报资料使用电子签名的，境外申请人/注册人还应在“CH1.11.5真实性和准确性声明”项下提交如下文件：<br  /></span><p><br  /></p><p><span>（一）关于注册申报资料使用电子签名的情况说明，并附使用电子签名的注册申报资料清单。<br  /><br  /></span></p><p><span>（二）境外申请人/注册人所在国（地区）已经建立完善的电子签名法律法规体系的证明文件，包括证明文件原文以及其中规定电子签名具有法律约束力等关键法规条款的中文译文。<br  /><br  /></span></p><p><span>（三）电子签名行为符合境外申请人/注册人所在国（地区）相关法规程序的说明文件，应详述在法规程序下获得可靠的电子签名的具体途径。<br  /><br  /></span></p><p><span>（四）境外申请人/注册人内部授权电子签名的法定代表人或者负责人的名单及其电子签名式样，必要时还可提交境外申请人/注册人关于电子签名的质量体系文件作为支持。<br  /><br  /></span></p><p><span>（五）境外申请人/注册人对于上述事项的真实性声明。境外申请人/注册人应保证其提交注册申报资料中使用的电子签名真实、完整、准确、可追溯，符合质量体系要求，电子签名行为符合所在国（地区）法规要求，同时作出承担相关法律责任的承诺。<br  /><br  /></span></p><p><span>三、关于进口医疗器械注册申请的公证要求，仍执行《关于调整部分医疗器械注册申请事项公证文件提交时间和形式的通告》（2020年第13号）。<br  /><br  /></span></p><p><span>特此通告。<br  /></span></p><p><span><br  /></span></p><p><span>器审中心</span></p><p><span>2020年9月29日</span></p><p><br  /></p></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="#757576"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><section><br  /></section></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_2.gif" /></p></section><section data-brushtype="text"><span>戳一下，更有料！</span></section></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984552&idx=2&sn=41fba839a467d1610657837d106ac4bb&chksm=843f367fb348bf6921f73b79ad7432570b6077d7f874937e343641f1656be4cc1bf9bd952cca&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>这16省，新建大批医院</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984486&idx=1&sn=1089291caebb8d990a44e9421c3e098f&chksm=843f3631b348bf2752a89411ff803fb3b4486784ddf457d2b749df8e15156378f40a47f3cf92&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>国产进口器械价差大，国家医保局发声</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984370&idx=1&sn=7b33719474e98cc108d6bace83aab438&chksm=843f36a5b348bfb3e4ef299bb5907b72967fdccad70d2a68bf4dca7c94ed16c7cc6445fb3abd&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>轻盘点丨必须知道的12家国外手术机器人公司</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984370&idx=2&sn=75c136ab1fc26eee1cb324cd8a984633&chksm=843f36a5b348bfb3eafa27f62c1001dc52b050b2188ba47004deb7efbe00322c57b0a5ef7a82&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>迈瑞之后，两家外企巨头“联姻”入主内窥镜领域</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984184&idx=1&sn=49c6beef3e2225ecd88b41e6d8851415&chksm=843f31efb348b8f9f7ad430f032e01c646c27704a3a1dd10d600efc75c46fef3ff3671a4a5b0&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>业务调整？瓦里安高管频繁人事变动</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984184&idx=2&sn=7b3a32fdfb230448669dbfa24a908aa9&chksm=843f31efb348b8f96245dc8e295db25e3954a21a1d159b819e49f06a392dff08d3b1cad1f536&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>CMEF 2020 十大必看内窥镜产品</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984045&idx=1&sn=8cc3da1a12595d99fb53f7cbb237e950&chksm=843f307ab348b96cdf1231486990aa498324f08ea9ca6b8837f7b3cfb3f94e28e3c99b948d8e&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1"><span>各专业收入排名公布，药学专业“几乎垫底”！</span></a><br  /></section><section><br  /></section><section><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984033&idx=1&sn=c039b3c37d0835b81fce05eb104fbd6a&chksm=843f3076b348b9605ce69bff0c2ebebdf9d5b096a4bbd2c7a8dee35746b249e6c0d477ce5d40&scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2" hasload="1"><span>2020中国最佳医学院校临床实力排行榜公布！</span></a><br  /></section><section><br  /></section><section><span><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652984032&idx=1&sn=a081e92963ce3e9ddb89889e348cf566&chksm=843f3077b348b9616f3ff6b7d9e22574edcf16cc7d896e14d90fca32237389b136f88681bdb3&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">CMEF 2020 十大必看超声</a></span></section></section></section></section></section></section></section></section><section><br  /></section><section><span>商务合作：4008228766@qixieke.com</span></section><section><br  /></section><section><p><img src="image/20201014/aad9f56b0707b5374bbac6273a663447_3.jpg" /></p></section>

		自动登录	找回密码
密码			立即注册