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進口器械備案

進口器械備案

法規依據

《關于第一類醫療器械備案有關事項的公告》((CFDA公告 2014年 第26號)(2014-5-30由CFDA總局發布、2014-6-1起實施)

(http://www.sda.gov.cn/WS01/CL0087/100816.html)

特別注意事項

       一、進口第一類醫療器械備案,向CFDA總局提交備案資料;

       二、香港、澳門、臺灣地區醫療器械的備案,參照進口醫療器械辦理;

       三、必須為《第一類醫療器械產品目錄》和相應《體外診斷試劑分類子目錄》中的第一類醫療器械;

       四、該醫療器械應在備案人注冊地或者生產地址所在國家(地區)已獲得醫療器械上市許可;

       五、備案人注冊地或者生產地址所在國家(地區)未將該產品作為醫療器械管理的,備案人需提供相關證明文件,包括備案人注冊地或者生產地址所在國家(地區)準許該產品合法上市銷售的證明文件;

       六、應由中國境內設立的代表機構或者指定中國境內的企業法人作為代理人辦理;

       七、備案表中“產品名稱”、“產品描述”和“預期用途”應與《第一類醫療器械產品目錄》相應內容一致(產品名稱應與目錄所列內容相同;產品描述、預期用途,應與目錄所列內容相同或少于目錄內容);

       八、 所提交資料項目應齊全,并符合備案資料形式要求;

       九、 證明性文件應在有效期內;

       十、備案人名稱、注冊地址、生產地址、規格型號應與境外證明文件一致;

       十一、指定代理人的委托書、代理人承諾書中的委托、承諾內容,應與備案內容一致;

       十二、申報資料應使用中文;根據外文資料翻譯的文件應同時提供原文;

       十三、 如無特別說明,原文資料均應為原件,并由備案人簽章,中文文本由代理人簽章;

       十四、如備案信息表中登載內容及產品技術要求發生變化,應向CFDA提交(變化情況說明+相關證明文件),并提出變更。

申報資料清單

       一、I類醫療器械備案申請表

       二、產品風險分析資料

       三、產品技術要求

       四、產品檢驗報告

       五、臨床評價資料

       六、生產制造信息

       七、產品說明書及最小銷售單元的包裝、標簽設計樣稿

       八、證明性文件

       九、符合性聲明

久順企管 技術支持

       一、提供備案流程及技術指導;

       二、提供備案申請資料范本;

       三、主導編寫相關申請資料、產品技術要求等文件;

       四、指導準備相關原產證明;

       五、審核申報資料、指導修訂,并向CFDA遞交;

       六、文件有償翻譯。

聚福彩票

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