2017醫(yī)療的器械全部法規(guī)匯總情況

實用標準文案目 錄1.醫(yī)療器械監(jiān)督管理條例 3醫(yī)療器械注冊管理辦法................................................................................................................................................................28體外診斷試劑注冊管理辦法................................................................................................................................................................47體外診斷試劑注冊管理辦法修正案................................................................................................................................................................70醫(yī)療器械說明書和標簽管理規(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)療器械臨床試驗質量管理規(guī)范................................................................................................................................................................90關于印發(fā)醫(yī)療器械應急審批程序的通知.............................................................................................................................................................116關于印發(fā)創(chuàng)新醫(yī)療器械特別審批程序（試行）的通知.............................................................................................................................................................119關于第一類醫(yī)療器械備案有關事項的公告.............................................................................................................................................................133醫(yī)療器械召回管理辦法.............................................................................................................................................................154關于發(fā)布第一類醫(yī)療器械產(chǎn)品目錄的通告.............................................................................................................................................................165精彩文檔實用標準文案關于發(fā)布醫(yī)療器械產(chǎn)品技術要求編寫指導原則的通告.............................................................................................................................................................231關于實施《醫(yī)療器械注冊管理辦法》和《體外診斷試劑注冊管理辦法》有關事項的通知235關于發(fā)布免于進行臨床試驗的第二類醫(yī)療器械目錄的通告.............................................................................................................................................................242關于發(fā)布免于進行臨床試驗的第三類醫(yī)療器械目錄的通告.............................................................................................................................................................356關于發(fā)布需進行臨床試驗審批的第三類醫(yī)療器械目錄的通告.............................................................................................................................................................378關于印發(fā)醫(yī)療器械檢驗機構開展醫(yī)療器械產(chǎn)品技術要求預評價工作規(guī)定的通知.............................................................................................................................................................382關于公布醫(yī)療器械注冊申報資料要求和批準證明文件格式的公告.............................................................................................................................................................385關于公布體外診斷試劑注冊申報資料要求和批準證明文件格式的公告.............................................................................................................................................................414關于發(fā)布體外診斷試劑臨床試驗技術指導原則的通告.............................................................................................................................................................435關于發(fā)布體外診斷試劑說明書編寫指導原則的通告.............................................................................................................................................................450關于實施第一類醫(yī)療器械備案有關事項的通知.............................................................................................................................................................461關于印發(fā)境內第三類和進口醫(yī)療器械注冊審批操作規(guī)范的通知.............................................................................................................................................................465精彩文檔實用標準文案關于印發(fā)境內第二類醫(yī)療器械注冊審批操作規(guī)范的通知.............................................................................................................................................................476關于發(fā)布醫(yī)療器械優(yōu)先審批程序的公告.............................................................................................................................................................492關于發(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.............................................................................................................................................................499關于發(fā)布醫(yī)療器械審評溝通交流管理辦法（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)質量管理規(guī)范.............................................................................................................................................................534關于發(fā)布醫(yī)療器械生產(chǎn)質量管理規(guī)范附錄無菌醫(yī)療器械的公告.............................................................................................................................................................549關于發(fā)布醫(yī)療器械生產(chǎn)質量管理規(guī)范附錄植入性醫(yī)療器械的公告.............................................................................................................................................................560關于發(fā)布醫(yī)療器械生產(chǎn)質量管理規(guī)范附錄體外診斷試劑的公告.............................................................................................................................................................574關于醫(yī)療器械生產(chǎn)日常監(jiān)督現(xiàn)場檢查工作指南的通知.............................................................................................................................................................587關于醫(yī)療器械生產(chǎn)經(jīng)營備案有關事宜的公告.............................................................................................................................................................596關于實施《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》有關事項的通知.............................................................................................................................................................607精彩文檔實用標準文案關于醫(yī)療器械生產(chǎn)質量管理規(guī)范執(zhí)行有關事宜的通告.............................................................................................................................................................640精彩文檔實用標準文案關于發(fā)布禁止委托生產(chǎn)醫(yī)療器械目錄的通告.............................................................................................................................................................642關于印發(fā)醫(yī)療器械生產(chǎn)企業(yè)分類分級監(jiān)督管理規(guī)定的通知.............................................................................................................................................................645關于印發(fā)國家重點監(jiān)管醫(yī)療器械目錄的通知.............................................................................................................................................................651關于發(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關于生產(chǎn)一次性使用無菌注、輸器具產(chǎn)品有關事項的通告.............................................................................................................................................................671關于印發(fā)《一次性使用無菌注射器等25種醫(yī)療器械生產(chǎn)環(huán)節(jié)風險清單和檢查要點》的通知.............................................................................................................................................................674關于印發(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)風險清單和檢查要點》的通知.............................................................................................................................................................675關于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)質量管理體系年度自查報告編寫指南的通告.............................................................................................................................................................676關于印發(fā)醫(yī)療器械生產(chǎn)質量管理規(guī)范定制式義齒現(xiàn)場檢查指導原則的通知.............................................................................................................................................................682關于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)供應商審核指南的通告.............................................................................................................................................................699精彩文檔實用標準文案關于發(fā)布醫(yī)療器械工藝用水質量管理指南的通告.............................................................................................................................................................704關于發(fā)布醫(yī)療器械生產(chǎn)企業(yè)質量控制與成品放行指南的通告.............................................................................................................................................................708醫(yī)療器械經(jīng)營監(jiān)督管理辦法.............................................................................................................................................................717醫(yī)療器械經(jīng)營質量管理規(guī)范...................................................