【CODEX】国家药品监督管理局2019年第46号公告附件（3-4）
三、有关要求
III. Relevant Requirements
（一）签章要求
(I) Requirements for Signature
按照《国务院关于在线政务服务的若干规定》，电子印章与实物印章具有同等法律效力，加盖电子印章的电子材料合法有效，可以作为办理政务服务事项的依据。行政相对人使用eRPS系统提交的电子申报资料应具有电子印章。电子印章是指境内医疗器械注册申请人、注册人（进口医疗器械生产企业代理人）专有的，基于可信密码技术生成身份标识，以电子数据图形表现的印章。持有CA的管理员可使用CA在电子申报资料中加盖本企业的电子印章。进口产品的电子版原文资料除加盖代理人的电子印章外还应提交纸质版公证文件的扫描件。
According to the Provisions of the State Council on Online Government Services, the electronic seal has the same legal effect as the physical seal. The electronic dossiers stamped with the electronic seal are legal and valid, and can be used as the basis for handling government services. Electronic application dossiers submitted through the eRPS system by administrative counterparts shall be attached with electronic seals. The electronic seal refers to the seal specific to the applicant and registrant of domestic medical device registration (the agent of the imported medical device manufacturer), which generates the identity mark based on the credible password technology and presents in the form of electronic data graphics. The administrator holding the CA can use the CA to stamp the electronic seal of the enterprise in the electronic application dossiers. The electronic dossiers of the imported product shall be submitted with a scanned copy of the notarized document in its paper version in addition to the electronic seal of the agent.
CODEX是为数不多能够为在全球市场寻求发展的医疗企业提供跨国沟通渠道的专业服务商。CODEX团队由包括医学博士在内的高学历资深的全职员工组成，多年来深耕于医疗服务领域。CODEX拥有生命科学专业且庞大的数据库，同时CODEX医学翻译服务通过了ISO9001:2015和ISO17100:2015双重质量体系认证。在本地化、文档翻译和医学文献翻译方面，CODEX能够提供40多种语言的全方位端到端医学内容和咨询服务。
我们专注于生命科学，与客户紧密合作，为客户提供精准的医学解决方案，与客户一起顺利应对全球市场、消费者以及监管和专利环境所面临的挑战。
