2017醫(yī)療器械全部法規(guī)匯總

1、目錄1.醫(yī)療器械監(jiān)督管理條例..............................................................................................................32.醫(yī)療器械注冊管理辦法...................................................................................

2、.........................283.體外診斷試劑注冊管理辦法....................................................................................................474.體外診斷試劑注冊管理辦法修正案............................................................

3、.............................705.醫(yī)療器械說明書和標(biāo)簽管理規(guī)定.............................................................................................716.醫(yī)療器械分類規(guī)則....................................................................

4、................................................787.醫(yī)療器械通用名稱命名規(guī)則....................................................................................................878.醫(yī)療器械臨床試驗質(zhì)量管理規(guī)范......................................

5、.......................................................909.關(guān)于印發(fā)醫(yī)療器械應(yīng)急審批程序的通知..............................................................................11610.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.....................................

6、................11911.關(guān)于第一類醫(yī)療器械備案有關(guān)事項的公告........................................................................13312.醫(yī)療器械召回管理辦法............................................................................................

7、............15413.關(guān)于發(fā)布第一類醫(yī)療器械產(chǎn)品目錄的通告........................................................................16514.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.....................................................23115.關(guān)于實施《醫(yī)療器械注冊管理辦法》和《體外診斷試劑

8、注冊管理辦法》有關(guān)事項的通知23516.關(guān)于發(fā)布免于進(jìn)行臨床試驗的第二類醫(yī)療器械目錄的通告.............................................24217.關(guān)于發(fā)布免于進(jìn)行臨床試驗的第三類醫(yī)療器械目錄的通告.............................................35618.關(guān)于發(fā)布需進(jìn)行臨床試驗審批的第三類醫(yī)療器械目錄的通告......................

9、...................37819.關(guān)于印發(fā)醫(yī)療器械檢驗機(jī)構(gòu)開展醫(yī)療器械產(chǎn)品技術(shù)要求預(yù)評價工作規(guī)定的通知.........38220.關(guān)于公布醫(yī)療器械注冊申報資料要求和批準(zhǔn)證明文件格式的公告.................................38521.關(guān)于公布體外診斷試劑注冊申報資料要求和批準(zhǔn)證明文件格式的公告.........................41422.關(guān)于發(fā)布體外診斷試劑臨床試驗技術(shù)指導(dǎo)

10、原則的通告.....................................................43523.關(guān)于發(fā)布體外診斷試劑說明書編寫指導(dǎo)原則的通告.........................................................45024.關(guān)于實施第一類醫(yī)療器械備案有關(guān)事項的通知...................................................

11、..............46125.關(guān)于印發(fā)境內(nèi)第三類和進(jìn)口醫(yī)療器械注冊審批操作規(guī)范的通知.....................................46526.關(guān)于印發(fā)境內(nèi)第二類醫(yī)療器械注冊審批操作規(guī)范的通知.................................................47627.關(guān)于發(fā)布醫(yī)療器械優(yōu)先審批程序的公告..................................

12、..........................................49228.關(guān)于發(fā)布創(chuàng)新醫(yī)療器械特別審批申報資料編寫指南的通告.............................................49929.關(guān)于發(fā)布醫(yī)療器械審評溝通交流管理辦法（試行）的通告.............................................50630.醫(yī)療器械生產(chǎn)監(jiān)督管理辦法........

13、........................................................................................51731.醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范................................................................................................53432.關(guān)于發(fā)布醫(yī)療器械生產(chǎn)質(zhì)量

14、管理規(guī)范附錄無菌醫(yī)療器械的公告.....................................54933.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.................................56034.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.....................................57435.關(guān)于醫(yī)療器械生產(chǎn)日常監(jiān)督現(xiàn)場檢查工作指南的通知..

15、...................................................58736.關(guān)于醫(yī)療器械生產(chǎn)經(jīng)營備案有關(guān)事宜的公告....................................................................59637.關(guān)于實施《醫(yī)療器械生產(chǎn)監(jiān)督管理辦法》和《醫(yī)療器械經(jīng)營監(jiān)督管理辦法》有關(guān)事項的通知..............................