國內器械備案

國內器械備案 

注意事項:       

       一、向(生產)所在地設區的市級藥監局遞交備案資料;

       二、申報產品必須在《第一類醫療器械產品目錄》中;

       三、應提交《產品技術要求》,主要包括(成品的性能指標+檢驗方法);

       四、產品名稱、產品描述、預期用途,應與《第一類醫療器械產品目錄》相應內容一致;

       五、申報資料項目應齊全,并符合備案資料形式要求;

       六、備案人名稱、注冊地址應與企業營業執照一致;

       七、變更應向原備案部門提交。

備案申報資料清單:   

       一、I類醫療器械備案申請表

       二、安全風險分析報告

       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標簽設計樣稿

       八、證明性文件(企業營業執照復印件、組織機構代碼證復印件等)

       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、指導準備相關證明性材料;

       五、審核申報資料、指導修訂,并向相應藥監局遞交;

       六、跟蹤、修訂,直到取證。

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