實(shí)用標(biāo)準(zhǔn)文案目 錄1.醫(yī)療器械監(jiān)督管理?xiàng)l例 3醫(yī)療器械注冊(cè)管理辦法................................................................................................................................................................28體外診斷試劑注冊(cè)管理辦法................................................................................................................................................................47體外診斷試劑注冊(cè)管理辦法修正案................................................................................................................................................................70醫(yī)療器械說(shuō)明書(shū)和標(biāo)簽管理規(guī)定................................................................................................................................................................71醫(yī)療器械分類規(guī)則................................................................................................................................................................78醫(yī)療器械通用名稱命名規(guī)則................................................................................................................................................................87醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范................................................................................................................................................................90關(guān)于印發(fā)醫(yī)療器械應(yīng)急審批程序的通知.............................................................................................................................................................116關(guān)于印發(fā)創(chuàng)新醫(yī)療器械特別審批程序（試行）的通知.............................................................................................................................................................119關(guān)于第一類醫(yī)療器械備案有關(guān)事項(xiàng)的公告.............................................................................................................................................................133醫(yī)療器械召回管理辦法.............................................................................................................................................................154關(guān)于發(fā)布第一類醫(yī)療器械產(chǎn)品目錄的通告.............................................................................................................................................................165精彩文檔實(shí)用標(biāo)準(zhǔn)文案關(guān)于發(fā)布醫(yī)療器械產(chǎn)品技術(shù)要求編寫指導(dǎo)原則的通告.............................................................................................................................................................231關(guān)于實(shí)施《醫(yī)療器械注冊(cè)管理辦法》和《體外診斷試劑注冊(cè)管理辦法》有關(guān)事項(xiàng)的通知235關(guān)于發(fā)布免于進(jìn)行臨床試驗(yàn)的第二類醫(yī)療器械目錄的通告.............................................................................................................................................................242關(guān)于發(fā)布免于進(jìn)行臨床試驗(yàn)的第三類醫(yī)療器械目錄的通告.............................................................................................................................................................356關(guān)于發(fā)布需進(jìn)行臨床試驗(yàn)審批的第三類醫(yī)療器械目錄的通告.............................................................................................................................................................378關(guān)于印發(fā)醫(yī)療器械檢驗(yàn)機(jī)構(gòu)開(kāi)展醫(yī)療器械產(chǎn)品技術(shù)要求預(yù)評(píng)價(jià)工作規(guī)定的通知.............................................................................................................................................................382關(guān)于公布醫(yī)療器械注冊(cè)申報(bào)資料要求和批準(zhǔn)證明文件格式的公告.............................................................................................................................................................385關(guān)于公布體外診斷試劑注冊(cè)申報(bào)資料要求和批準(zhǔn)證明文件格式的公告.............................................................................................................................................................414關(guān)于發(fā)布體外診斷試劑臨床試驗(yàn)技術(shù)指導(dǎo)原則的通告.............................................................................................................................................................435關(guān)于發(fā)布體外診斷試劑說(shuō)明書(shū)編寫指導(dǎo)原則的通告.............................................................................................................................................................450關(guān)于實(shí)施第一類醫(yī)療器械備案有關(guān)事項(xiàng)的通知.............................................................................................................................................................461關(guān)于印發(fā)境內(nèi)第三類和進(jìn)口醫(yī)療器械注冊(cè)審批操作規(guī)范的通知.............................................................................................................................................................465精彩文檔實(shí)用標(biāo)準(zhǔn)文案關(guān)于印發(fā)境內(nèi)第二類醫(yī)療器械注冊(cè)審批操作規(guī)范的通知.............................................................................................................................................................476關(guān)于發(fā)布醫(yī)療器械優(yōu)先審批程序的公告.............................................................................................................................................................492關(guān)于發(fā)布創(chuàng)新醫(yī)療器械特別審批申報(bào)資料編寫指南的通告.............................................................................................................................................................499關(guān)于發(fā)布醫(yī)療器械審評(píng)溝通交流管理辦法（試行）的通告.............................................................................................................................................................506醫(yī)療器械生產(chǎn)監(jiān)督管理辦法.............................................................................................................................................................517醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范.............................................................................................................................................................534關(guān)于發(fā)布醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范附錄無(wú)菌醫(yī)療器械的公告.............................................................................................................................................................549關(guān)于發(fā)布醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范附錄植入性醫(yī)療器械的公告.............................................................................................................................................................560關(guān)于發(fā)布醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范附錄體外診斷試劑的公告.............................................................................................................................................................574關(guān)于醫(yī)療器械生產(chǎn)日常監(jiān)督現(xiàn)場(chǎng)檢查工作指南的通知.............................................................................................................................................................587關(guān)于醫(yī)療器械生產(chǎn)經(jīng)營(yíng)備案有關(guān)事宜的公告.............................................................................................................................................................596關(guān)于實(shí)施《醫(yī)療器械生產(chǎn)監(jiān)督管理辦法》和《醫(yī)療器械經(jīng)營(yíng)監(jiān)督管理辦法》有關(guān)事項(xiàng)的通知.............................................................................................................................................................607精彩文檔實(shí)用標(biāo)準(zhǔn)文案關(guān)于醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范執(zhí)行有關(guān)事宜的通告.............................................................................................................................................................640精彩文檔實(shí)用標(biāo)準(zhǔn)文案關(guān)于發(fā)布禁止委托生產(chǎn)醫(yī)療器械目錄的通告.............................................................................................................................................................642關(guān)于印發(fā)醫(yī)療器械生產(chǎn)企業(yè)分類分級(jí)監(jiān)督管理規(guī)定的通知.............................................................................................................................................................645關(guān)于印發(fā)國(guó)家重點(diǎn)監(jiān)管醫(yī)療器械目錄的通知.............................................................................................................................................................651關(guān)于發(fā)布醫(yī)療器械產(chǎn)品出口銷售證明管理規(guī)定的通告.............................................................................................................................................................655藥品醫(yī)療器械飛行檢查辦法.............................................................................................................................................................662關(guān)于生產(chǎn)一次性使用無(wú)菌注、輸器具產(chǎn)品有關(guān)事項(xiàng)的通告.............................................................................................................................................................671關(guān)于印發(fā)《一次性使用無(wú)菌注射器等25種醫(yī)療器械生產(chǎn)環(huán)節(jié)風(fēng)險(xiǎn)清單和檢查要點(diǎn)》的通知.............................................................................................................................................................674關(guān)于印發(fā)《一次性使用塑料血袋等21種醫(yī)療器械生產(chǎn)環(huán)節(jié)風(fēng)險(xiǎn)清單和檢查要點(diǎn)》的通知.............................................................................................................................................................675關(guān)于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)質(zhì)量管理體系年度自查報(bào)告編寫指南的通告.............................................................................................................................................................676關(guān)于印發(fā)醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范定制式義齒現(xiàn)場(chǎng)檢查指導(dǎo)原則的通知.............................................................................................................................................................682關(guān)于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)供應(yīng)商審核指南的通告.............................................................................................................................................................699精彩文檔實(shí)用標(biāo)準(zhǔn)文案關(guān)于發(fā)布醫(yī)療器械工藝用水質(zhì)量管理指南的通告.............................................................................................................................................................704關(guān)于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)質(zhì)量控制與成品放行指南的通告.............................................................................................................................................................708醫(yī)療器械經(jīng)營(yíng)監(jiān)督管理辦法.............................................................................................................................................................717醫(yī)療器械經(jīng)營(yíng)質(zhì)量管理規(guī)范...................................................