版權(quán)說明:本文檔由用戶提供并上傳,收益歸屬內(nèi)容提供方,若內(nèi)容存在侵權(quán),請(qǐng)進(jìn)行舉報(bào)或認(rèn)領(lǐng)
文檔簡介
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)療器械說明書和標(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)布體外診斷試劑說明書編寫指導(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)營監(jiān)督管理辦法.............................................................................................................................................................717醫(yī)療器械經(jīng)營質(zhì)量管理規(guī)范...................................................
溫馨提示
- 1. 本站所有資源如無特殊說明,都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請(qǐng)下載最新的WinRAR軟件解壓。
- 2. 本站的文檔不包含任何第三方提供的附件圖紙等,如果需要附件,請(qǐng)聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
- 3. 本站RAR壓縮包中若帶圖紙,網(wǎng)頁內(nèi)容里面會(huì)有圖紙預(yù)覽,若沒有圖紙預(yù)覽就沒有圖紙。
- 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
- 5. 人人文庫網(wǎng)僅提供信息存儲(chǔ)空間,僅對(duì)用戶上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理,對(duì)用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯,并不能對(duì)任何下載內(nèi)容負(fù)責(zé)。
- 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容,請(qǐng)與我們聯(lián)系,我們立即糾正。
- 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶因使用這些下載資源對(duì)自己和他人造成任何形式的傷害或損失。
最新文檔
- 2024年度年福建省高校教師資格證之高校教師職業(yè)道德全真模擬考試試卷A卷含答案
- 2024年xx村年度脫貧戶、監(jiān)測(cè)戶增收工作總結(jié)
- 牛津譯林版英語高三上學(xué)期期末試題及答案指導(dǎo)
- 機(jī)電工程師招聘面試題與參考回答(某大型國企)
- 新修訂《疫苗流通和預(yù)防接種管理?xiàng)l例》培訓(xùn)試題及答案
- 2024年簡化貨品采購協(xié)議格式
- 2024年限定區(qū)域分銷商協(xié)議條款
- 2024年度工程領(lǐng)域勞務(wù)協(xié)議范本
- 2024年新汽車租賃經(jīng)營協(xié)議樣本
- 2024全新保健品商業(yè)合作協(xié)議樣本
- 山東省濟(jì)南市歷下區(qū)2023-2024學(xué)年八年級(jí)上學(xué)期期中語文試題
- 圖神經(jīng)網(wǎng)絡(luò)在生物醫(yī)學(xué)影像分析中的應(yīng)用
- 淺談管理者的自我管理
- 第一章 結(jié)構(gòu)及其設(shè)計(jì) 課件-2023-2024學(xué)年高中通用技術(shù)蘇教版(2019)必修《技術(shù)與設(shè)計(jì)2》
- 語文教學(xué)常規(guī)檢查表
- “思政”課社會(huì)實(shí)踐
- 臨時(shí)用電漏電保護(hù)器運(yùn)行檢測(cè)記錄表
- 復(fù)雜性尿路感染
- 重度殘疾兒童送教上門
- 膀胱癌綜合治療新進(jìn)展
- 音樂ppt課件《小小的船》
評(píng)論
0/150
提交評(píng)論