辦理三類醫(yī)療器械嚴(yán)格嗎？需要什么資料？

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">三類醫(yī)療器械許可證申請的時候?qū)彶闀貏e仔細(xì)，各方面把控的很嚴(yán)，對其安全性、有效性必須嚴(yán)格控制。


inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">一，辦理三類醫(yī)療器械許可證對地址的要求：
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">1、普通類：辦公面積不少于100平，倉庫面積不少于60平；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">2、一次性無菌：辦公面積不少于60平，倉庫面積不少于80；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">3、體外診斷試劑：辦公面積不少于60平，倉庫面積不少于100平，冷藏室面積不少于40立方；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">4、還需三名本科學(xué)歷相關(guān)醫(yī)療行業(yè)的人員。


inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">二、注意事項：
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">1、辦公地址需商用性質(zhì)，面積以房產(chǎn)證上建筑面積為準(zhǔn)；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">2、體外診斷試劑必須要有冷藏室，且40立方，醫(yī)用冰柜是沒用的，必須是冷藏室；因為涉及到后續(xù)老師到現(xiàn)場勘查；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">3、三名人員必須是本科醫(yī)療行業(yè)的，后續(xù)辦理三類醫(yī)療器械許可證，那邊老師要約談的，所以這人員很重要，年檢也是涉及這3名人員的，所以辦理三類醫(yī)療器械許可證蕞重要的就是人員。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">4、如果注冊地址是園區(qū)地址，可能還需要做地址遷移，因為不是每個園區(qū)地址都能增加相關(guān)三類醫(yī)療器械的經(jīng)營范圍，沒有這個經(jīng)營范圍就不能申請三類醫(yī)療器械許可證；（有需要可以戳我）
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">三、辦理流程：
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">1、申請資料提交
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">①相關(guān)人員3個（醫(yī)學(xué)相關(guān)inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 0);">學(xué)歷inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap;">，大專以上學(xué)歷）及身份證照片、簡歷
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">②產(chǎn)品授權(quán)書(加蓋上家公章)
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">③上家營業(yè)執(zhí)照復(fù)印件（加蓋上家公章）
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">④上家醫(yī)療器械經(jīng)營或生產(chǎn)許可證&產(chǎn)品注冊證復(fù)印件（加蓋上家公章）
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">⑤企業(yè)告知進(jìn)銷存軟件及法人郵箱手機(jī)號、各人員手機(jī)號
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">⑥自己企業(yè)營業(yè)執(zhí)照復(fù)印件、公章、法人章
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">⑦上家提供的培訓(xùn)證明
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">2、進(jìn)行審查約談
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">資料提交給相關(guān)的部門之后，相關(guān)人員會對這些資料進(jìn)行初步的審查，然后對企業(yè)資格進(jìn)行驗收。然后也會約談法人和質(zhì)量負(fù)責(zé)人，詢問業(yè)務(wù)和人員的基本情況。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">3、許可證的送達(dá)
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">當(dāng)企業(yè)通過三類醫(yī)療器械經(jīng)營許可證，則會在食品藥品監(jiān)督管理局的官網(wǎng)公示。10個工作日內(nèi)，許可證會快遞給申請人