未获得境外医疗器械上市许可的第二三类境外医疗器械首次注册

1、the party. Focus on honesty and self-discipline standards of four clean four consciousness, hold the work principle and various violations of party discipline punishment . 2. series spoke. To XI on ruling acting political XI General Secretary series important speech reading (2016 version) XI General Secretary important speech articles selected (leaders reading) and out poverty for basic textbook, in-depth learning understand XI General Secretary series important speech spirit and on Fujian work

2、of series important indicates spirit, understand on reform development stable, and Interior diplomatic defense, and rule party ruling army of important discusses, understand throughout which of Marx doctrine position views method, Grasp the true faith through the pursuit of, historical sense, sincere feelings for the people, pragmatic style of thought. Should pay attention to the overall grasp and master relationship and prevent fragmentation. Address learning series, attention should be paid ba

3、sed on persisting and developing socialism with Chinese characteristics to the theme, focuses on understanding comrade XI as General Secretary of the CPC Central Committee on governance of the new concept of new ideas and new strategies. (1) the deep understanding we are carrying out the great struggle of history with many new features that Chinas development is an important period of strategic opportunities and the same connotation. (2) to grasp a firm system of socialism with Chinese character

4、istics theory of confidence, confidence, confidence, winning complete the building of a well-off society and realize two 100 year goal dreams, China and the great rejuvenation of the Chinese nation. (3) understand the domestic and international situations, coordination of five in one overall layout and four comprehensive strategy. (4) a deep understanding of innovation, coordination, development of green, open, shared ideas, adapt to new normal, grasp, leading economic development, greater empha

5、sis on advancing the supply side structural reform, to lead the development of new development practices. Vigorous implementation of innovation-driven development strategy, strive to enhance the overall coordination of development to promote harmonious coexistence between man and nature, form the opening to the new system, focus on the practice of people-centred development. (5) in-depth understand full deepening reform, advance national governance system and governance capacity modern; makes ma

6、rket in resources configuration in the up decisive role and better play Government role; without shake insisted China basic economic system, promoted various ownership economic health development; advance area way construction, and Beijing Jin JI collaborative development, and Yangtze River economic with development; full law ruling, construction China features Socialist rule of law system; development Socialist democracy, insisted China features socialist political development road; Fostering a

7、nd practicing the Socialist core values, enhance cultural values of confidence, self-confidence, building Socialist culture in China set up the overall national security concept, respect the sovereignty of networks, build global Internet governance system adhere to the correct view, building human fates. (6) to grasp the full strictness requirement, and strict adherence to the partys political discipline and rules, loyal, clean, play, strengthen the wind against corruption, adhere to the Tigers

8、and fly. (7) the奥咨达医疗器械服务集团只专注于医疗器械领域文章来源：奥咨达医疗器械服务集团好东西记得要分享哦！未获得境外医疗器械上市许可的第二、三类境外医疗器械首次注册一、项目名称：首次进口医疗器械产品注册二、许可内容：未获得境外医疗器械上市许可的第二、三类境外医疗器械首次注册三、实施依据：医疗器械监督管理条例、医疗器械注册管理办法四、收费：不收费五、数量限制：本许可事项无数量限制六、申请人提交材料目录：资料编号(一)境外医疗器械注册申请表；资料编号(二)医疗器械生产企业资格证明；资料编号(三)申报者的营业执照副本和生产企业授予的代理注册的委托书；资料编号(四)产品技术报告；资料编号(五)安全风险分析报告；资料编号(六)适用的产品标准及说明；资料编号(七)产品性能自测报告；资料编号(八)医疗器械检测机构出具的产品注册检测报告；资料编号(九)医疗器械临床试验资料；资料编号(十)医疗器械说明书；资料编号(十一)产品生产质量体系考核(认证)有效证明文件；资料编号(十二)生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明；资料编号(十三)在中国指定售后服

9、务机构的委托书、受委托机构的承诺书及资格证明文件；资料编号(十四)所提交材料真实性的自我保证声明；资料编号(十五)其他。七、对申报资料的要求：(一)申报资料的一般要求： 1、申报资料首页为申报资料项目目录，目录中申报资料项目按医疗器械注册管理办法附件9的顺序排列。每项资料加封页，封页上注明产品名称、申请人名 称，右上角注明该项资料名称。各项资料之间应当使用明显的区分标志，并标明各项资料名称或该项资料所在目录中的序号。整套资料应装订成册。2、申报资料一式一份，申报资料应使用A4规格纸张打印，内容完整、清楚、不得涂改，政府及其他机构出具的文件按原件尺寸提供。3、申报资料的复印件应清晰。4、各项(上市批件、标准、检测报告、说明书)申报资料中的产品名称应与申请表中填写的产品名称实质性内容相对应。若有商品名，应标注商品名。申报资料应当使用中文，根据外文资料翻译的申报资料，应当同时提供原文。中文的签章执行2004499号文。(二)申报资料的具体要求：1、境外医疗器械注册申请表(1)医疗器械注册申请表可从下载“医疗器械(体外诊断试剂)注册电子申报软件2010(含使用手册)”；(2)医疗器械注册申请表是注册申请的重要资料之一，表内各项应符合填表说明要求。2、医疗器械生产企业资格证明(1)可以合法生产医疗器械的资格证明文件； (2)复印件须经原出证机关签章或者经当地公证机构公证；(3)在有效期内(如有)。3、申报者的营业执照副本和生产企业授予的代理注册的委托书(1)申报者的营业执照副本可以是复印件，但需加盖证书所属企业公章；在有效期内。(2)代理注册委托书应由生产企业签章。4、产品技术报告应由生产企业签章。5、安全风险分析报告应由生产企业签章。

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