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id="scnlwhi" class="leftbox clearfix"><h1>青海質(zhì)量追溯流程歡迎來電上海貞碼信息科技供應(yīng)</h1><div id="uo0nddp" class="proBig"><div id="eaayufr" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="gmmnqcv" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="n0bnyfb" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>青海質(zhì)量追溯流程,UDI</p><p><span>***更新：</span>2020-09-03 21:34:12</p><p><span id="click" >瀏覽次數(shù)：5次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="htj3fg3" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">上海貞碼信息科技有限公司</a></p><p><span>聯(lián)系人：</span>貞碼科技陳先生</p><p><span>郵箱: </span>77740203@qq.com</p><p><span>電話: </span>18601787597</p><p><span>傳真: </span>18601_</p><p><span>網(wǎng)址: </span>http://www.idcodema.com</p><p><span>手機(jī): </span>18601-787597</p><p><span>地址: </span>上海市閔行區(qū)蓮花南路2899號蓮谷科技園1號樓A305室</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="jquryvv" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="cepqqmb" class="box"><p><p style="text-indent:25px">醫(yī)療器械UDI注冊申報服務(wù)：注冊條件。申報主體。擬從事醫(yī)療器械UDI生產(chǎn)且在境內(nèi)銷售的境內(nèi)生產(chǎn)企業(yè)；擬出口醫(yī)療器械UDI到中國的境外生產(chǎn)企業(yè)；擬在中國大陸銷售醫(yī)療器械UDI產(chǎn)品的港澳臺地區(qū)的生產(chǎn)企業(yè)；醫(yī)療器械UDI注冊(備案)類型：中國醫(yī)療器械UDI按管理類別分為Ⅰ類、Ⅱ類、Ⅲ類醫(yī)療器械UDI，具體產(chǎn)品管理類別的歸屬，以國家食品藥品監(jiān)督管理部門發(fā)布的《醫(yī)療器械UDI分類規(guī)則》、《醫(yī)療器械UDI分類目錄》以及不定時發(fā)布的分類界定通知為主要依據(jù)。按照醫(yī)療器械UDI的類別、注冊不同階段等情況，青海質(zhì)量追溯流程，醫(yī)療器械UDI的注冊可以分為初次注冊、注冊變更，青海質(zhì)量追溯流程、延續(xù)注冊三個類型，青海質(zhì)量追溯流程。醫(yī)療器械UDI性是首要原則，是確保產(chǎn)品精確識別的基礎(chǔ)。青海質(zhì)量追溯流程</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海質(zhì)量追溯流程,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png"></div><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營質(zhì)量管理規(guī)范：從事第二類、第三類醫(yī)療器械UDI批發(fā)業(yè)務(wù)和第三類醫(yī)療器械UDI零售業(yè)務(wù)的企業(yè)還應(yīng)當(dāng)制定購貨者資格審核、醫(yī)療器械UDI追蹤溯源、質(zhì)量管理制度執(zhí)行情況考核的規(guī)定。第三類醫(yī)療器械UDI經(jīng)營企業(yè)應(yīng)當(dāng)建立質(zhì)量管理自查制度，于每年年底前向所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門提交年度自查報告。重點查看從事第二類、第三類醫(yī)療器械UDI批發(fā)業(yè)務(wù)和第三類醫(yī)療器械UDI零售業(yè)務(wù)的企業(yè)制定的購貨者資格審核制度、醫(yī)療器械UDI追蹤溯源制度、質(zhì)量管理制度執(zhí)行情況考核規(guī)定和第三類醫(yī)療器械UDI經(jīng)營企業(yè)質(zhì)量管理自查和年度報告制度；抽查企業(yè)實施記錄，確認(rèn)企業(yè)是否實施相關(guān)規(guī)定與制度。青海UDI醫(yī)療器械UDI標(biāo)識是醫(yī)療器械的身份證。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海質(zhì)量追溯流程,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817450019531/4187422.png"></div><p style="text-indent:25px">企業(yè)應(yīng)當(dāng)依據(jù)本規(guī)范建立覆蓋醫(yī)療器械UDI經(jīng)營全過程的質(zhì)量管理制度，并保存相關(guān)記錄或者檔案，包括以下內(nèi)容：（一）質(zhì)量管理機(jī)構(gòu)或者質(zhì)量管理人員的職責(zé)；（二）質(zhì)量管理的規(guī)定；（三）采購、收貨、驗收的規(guī)定（包括采購記錄、驗收記錄、隨貨同行單等）；（四）供貨者資格審核的規(guī)定（包括供貨者及產(chǎn)品合法性審核的相關(guān)證明文件等）；（五）庫房貯存、出入庫、運輸管理的規(guī)定（包括溫濕度記錄、入庫記錄、定期檢查記錄、出庫記錄等）；</p><p style="text-indent:25px">醫(yī)療器械UDI國際化合規(guī)性，您了解多少？第九條、注冊人/備案人應(yīng)當(dāng)按照醫(yī)療器械UDI標(biāo)識的編制標(biāo)準(zhǔn)創(chuàng)建、維護(hù)醫(yī)療器械UDI標(biāo)識。醫(yī)療器械UDI標(biāo)識編制標(biāo)準(zhǔn)應(yīng)當(dāng)符合國家藥品監(jiān)督管理局以及符合本規(guī)則要求的發(fā)碼機(jī)構(gòu)制定的相關(guān)標(biāo)準(zhǔn)。第十條、發(fā)碼機(jī)構(gòu)應(yīng)當(dāng)為中國境內(nèi)的法人機(jī)構(gòu)，具備完善的管理制度和運行體系，確保按照其標(biāo)準(zhǔn)創(chuàng)建的醫(yī)療器械UDI標(biāo)識的性，并符合國家數(shù)據(jù)安全有關(guān)要求。發(fā)碼機(jī)構(gòu)應(yīng)當(dāng)向注冊人/備案人提供執(zhí)行其標(biāo)準(zhǔn)的流程并指導(dǎo)實施，應(yīng)當(dāng)將其編碼標(biāo)準(zhǔn)上傳至醫(yī)療器械UDI標(biāo)識數(shù)據(jù)庫并動態(tài)維護(hù)，每年1月31日前向國家藥品監(jiān)督管理局提交按照其標(biāo)準(zhǔn)創(chuàng)建的標(biāo)識上一年度的報告。國家鼓勵發(fā)碼機(jī)構(gòu)采用相關(guān)國際標(biāo)準(zhǔn)建立標(biāo)識運行體系。醫(yī)療器械UDI標(biāo)識系統(tǒng)由醫(yī)療器械標(biāo)識、數(shù)據(jù)載體和數(shù)據(jù)庫組成。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海質(zhì)量追溯流程,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345816979453125/7647463.png"></div><p style="text-indent:25px">從產(chǎn)業(yè)角度看，對于醫(yī)療器械UDI生產(chǎn)企業(yè)，利用標(biāo)識有助于提升企業(yè)信息化管理水平，建立產(chǎn)品追溯體系，加強(qiáng)行業(yè)自律，提升企業(yè)管理效能，助推醫(yī)療器械UDI產(chǎn)業(yè)高質(zhì)量發(fā)展。對于醫(yī)療器械UDI經(jīng)營企業(yè)，利用標(biāo)識，可建立符合現(xiàn)代化的物流體系，實現(xiàn)醫(yī)療器械UDI供應(yīng)鏈的透明化、可視化、智能化。對于醫(yī)療機(jī)構(gòu)，利用標(biāo)識，有利于減少用械差錯，提升院內(nèi)耗材管理水平，維護(hù)患者安全。對于衛(wèi)生行政管理部門，利用標(biāo)識，可強(qiáng)化對醫(yī)療用械行為的規(guī)范化管理，推動建立健康醫(yī)療大數(shù)據(jù)，提高衛(wèi)生管理效率，助力健康中國戰(zhàn)略。對于醫(yī)療器械UDI經(jīng)營企業(yè)，利用標(biāo)識，可建立符合現(xiàn)代化的物流體系。河北電子信息追溯系統(tǒng)</p><p style="text-indent:25px">醫(yī)療器械UDI產(chǎn)品標(biāo)識是識別注冊人/備案人、醫(yī)療器械型號規(guī)格和包裝的代碼。青海質(zhì)量追溯流程</p><p style="text-indent:25px">醫(yī)療器械UDI國際化合規(guī)性，您了解多少？第七條、醫(yī)療器械UDI標(biāo)識包括產(chǎn)品標(biāo)識和生產(chǎn)標(biāo)識。產(chǎn)品標(biāo)識為識別注冊人/備案人、醫(yī)療器械UDI型號規(guī)格和包裝的代碼；生產(chǎn)標(biāo)識由醫(yī)療器械UDI生產(chǎn)過程相關(guān)信息的代碼組成，根據(jù)監(jiān)管和實際應(yīng)用需求，可包含醫(yī)療器械UDI序列號、生產(chǎn)批號、生產(chǎn)日期、失效日期等。產(chǎn)品發(fā)生可能影響醫(yī)療器械UDI識別、追溯的變更或者監(jiān)管要求變化時，應(yīng)當(dāng)創(chuàng)建新的產(chǎn)品標(biāo)識。醫(yī)療器械UDI停止銷售、使用的，其產(chǎn)品標(biāo)識不得用于其他醫(yī)療器械UDI；重新銷售、使用時，可使用原產(chǎn)品標(biāo)識。青海質(zhì)量追溯流程</p><p style="text-indent:25px">上海貞碼信息科技有限公司致力于通信產(chǎn)品，是一家服務(wù)型公司。公司業(yè)務(wù)分為生碼打碼客戶端，碼標(biāo)，智能追溯，掃碼通VA等，目前不斷進(jìn)行創(chuàng)新和服務(wù)改進(jìn)，為客戶提供良好的產(chǎn)品和服務(wù)。公司將不斷增強(qiáng)企業(yè)重點競爭力，努力學(xué)習(xí)行業(yè)知識，遵守行業(yè)規(guī)范，植根于通信產(chǎn)品行業(yè)的發(fā)展。貞碼科技憑借創(chuàng)新的產(chǎn)品、專業(yè)的服務(wù)、眾多的成功案例積累起來的聲譽和口碑，讓企業(yè)發(fā)展再上新高。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/1146512.html</p></div></div></div></div></div><div id="niyx0yu" class="page-right twoColRt"><div id="0jgqcdk" 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