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class="CurrChnlCls">UDI動態</a> </div> <div class="bgc-white detail-container"> <div class="detitle">醫療器械安全宣傳周∣全方位帶您了解醫療器械UDI?。ǖ谌?/div> <div class="stime"> 發布時間：2022-07-21 來源：江蘇省藥品監督管理局 </div> <div class="article"> <div class="view TRS_UEDITOR trs_paper_default trs_web"><p style="text-indent: 2em;">醫療器械事關人民生命健康。UDI作為醫療器械的身份證，第三類醫療器械已經要求全部覆蓋，唯一標識將逐漸覆蓋所有器械。2022年7月18日至23日全省組織開展2022年“江蘇省醫療器械安全宣傳周”活動，為了更好的幫助大家了解UDI，小編針對大家都比較關心的重點問題進行了整理與解答，從基礎知識、相關法規標準、實施過程及步驟、數據庫使用、發碼機構、后續應用等方面幫助大家更好的了解UDI體系脈絡。今天和大家一起分享UDI科普問答第三篇，希望對小伙伴們有所幫助！</p><p style="text-indent: 2em;">二、UDI相關的標準法規問答</p><p style="text-indent: 2em;">21.有關醫療器械唯一標識的法規和政策文件有哪些？</p><p style="text-indent: 2em;">（1）國家藥監局綜合司國家衛生健康委辦公廳關于印發醫療器械唯一標識系統試點工作方案的通知（藥監綜械注〔2019〕56號）</p><p style="text-indent: 2em;">（2）國家藥監局關于發布醫療器械唯一標識系統規則的公告（2019年第66號）附件：醫療器械唯一標識系統規則</p><p style="text-indent: 2em;">（3）國家藥監局《醫療器械唯一標識系統規則》解讀索引號FGWJ-2020-1759</p><p style="text-indent: 2em;">（4）國家藥監局關于做好第一批實施醫療器械唯一標識工作有關事項的通告（2019年第72號）</p><p style="text-indent: 2em;">（5）國家藥監局國家衛生健康委國家醫保局關于深入推進試點做好第一批實施醫療器械唯一標識工作的公告（2020年第106號）</p><p style="text-indent: 2em;">（6）國家藥監局國家衛生健康委國家醫保局關于做好第二批實施醫療器械唯一標識工作的公告（2021年第114號）</p><p style="text-indent: 2em;">（7）《醫療器械監督管理條例》第三十八條：國家根據醫療器械產品類別，分步實施醫療器械唯一標識制度，實現醫療器械可追溯，具體辦法由國務院藥品監督管理部門會同國務院有關部門制定。</p><p style="text-indent: 2em;">（8）《醫療器械注冊與備案管理辦法》第一百零一條：國家藥品監督管理局建立并分步實施醫療器械唯一標識制度，申請人、備案人應當按照相關規定提交唯一標識相關信息，保證數據真實、準確、可溯源。</p><p style="text-indent: 2em;">（9）《體外診斷試劑注冊與備案管理辦法》第一百零一條：國家藥品監督管理局建立并分步實施醫療器械唯一標識制度，申請人、備案人應當按照相關規定提交唯一標識相關信息，保證數據真實、準確、可溯源。</p><p style="text-indent: 2em;">（10）《醫療器械生產監督管理辦法》第三十六條：醫療械注冊人、備案人、受托生產企業應當按照國家實施醫療器械唯一標識的有關要求，開展賦碼、數據上傳和維護更新，保證信息真實、準確、完整和可追溯。</p><p style="text-indent: 2em;">第七十九條：有下列情形之一的，由藥品監督管理部門依職責責令限期改正；拒不改正的，處1萬元以上5萬元以下罰款；情節嚴重的，處5萬元以上10萬元以下罰款：</p><p style="text-indent: 2em;">（二）未按照國家實施醫療器械唯一標識的有關要求，組織開展賦碼、數據上傳和維護更新等工作的。</p><p style="text-indent: 2em;">（11）《醫療器械經營監督管理辦法》第三十條：醫療器械經營企業應當建立并實施產品追溯制度，保證產品可追溯。醫療器械經營企業應當按照國家有關規定執行醫療器械唯一標識制度。</p><p style="text-indent: 2em;">22.醫療器械唯一標識系統建設遵循哪些原則？</p><p style="text-indent: 2em;">（1）醫療器械唯一標識系統建設應當積極借鑒國際標準，遵循政府引導、企業落實、統籌推進、分步實施的原則。（《醫療器械唯一標識系統規則》第四條）</p><p style="text-indent: 2em;">（2）注冊人/備案人作為第一責任人負責落實，積極應用唯一標識提升產品質量和企業管理水平（《醫療器械唯一標識系統規則》解讀）</p><p style="text-indent: 2em;">23.醫療器械唯一標識相關標準有哪些?</p><p style="text-indent: 2em;">24.問：UDI 的相關政策和文件如何查詢？</p><p style="text-indent: 2em;">（1）可到國家藥監局官方網站查詢，具體網址：</p><p style="text-indent: 2em;">https://udi.nmpa.gov.cn/toMessageList.html?flag=2</p><p style="text-indent: 2em;">（2）也可到江蘇藥監局官方網站查詢，具體網址：</p><p style="text-indent: 2em;">http://da.jiangsu.gov.cn/</p><p style="text-indent: 2em; text-align: right;"> 　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　（行政審批處）</p><p><br/></p></div> </div> </div> </section> </div> </main> <footer> <p>Copyright ? 2022 中國醫療器械信息網 All Rights Reserved. <a target="_blank" style="color: #ffffff;"><img style="vertical-align: middle;" src="../../../images/beian-202304-icon.png" alt="" /> 京公網安備 11010202010536號</a> 京ICP備05064905號-5</p> <p>E-mail： 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