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國家藥監(jiān)局全面強(qiáng)化醫(yī)用口罩監(jiān)管 醫(yī)用口罩質(zhì)量狀況持續(xù)良好
發(fā)布日期：2021-12-28 09:42:40瀏覽量：1595

      12月7日，國家市場監(jiān)督管理總局以“加強(qiáng)口罩質(zhì)量監(jiān)管，保障人民健康安全，服務(wù)疫情防控大局”為主題，召開第四季度例行新聞發(fā)布會(huì)。會(huì)上，國家藥監(jiān)局器械監(jiān)管司負(fù)責(zé)同志表示，國家藥監(jiān)局深入貫徹落實(shí)黨中央、國務(wù)院關(guān)于疫情防控醫(yī)療器械監(jiān)管工作有關(guān)要求，依法履職、嚴(yán)格監(jiān)管，將醫(yī)用口罩監(jiān)管納入年度重點(diǎn)工作，全面強(qiáng)化醫(yī)用口罩監(jiān)管、全面開展風(fēng)險(xiǎn)隱患排查、全面加強(qiáng)醫(yī)用口罩質(zhì)量抽檢、精準(zhǔn)開展醫(yī)用口罩飛行檢查，大力加強(qiáng)質(zhì)量安全監(jiān)管，協(xié)助有關(guān)部門做好供應(yīng)保障工作。

　　今年以來，國家藥監(jiān)局全面強(qiáng)化醫(yī)用口罩監(jiān)管。2月，市場監(jiān)管總局、工信部、國資委和國家藥監(jiān)局四部委聯(lián)合印發(fā)《深入推進(jìn)口罩質(zhì)量監(jiān)管促進(jìn)口罩質(zhì)量提升專項(xiàng)整治行動(dòng)方案》，要求全面排查風(fēng)險(xiǎn)隱患、加強(qiáng)醫(yī)用口罩等的產(chǎn)品質(zhì)量監(jiān)督抽查、強(qiáng)化不合格產(chǎn)品處理、突出網(wǎng)售產(chǎn)品質(zhì)量監(jiān)管、嚴(yán)厲打擊各類違法行為。3月，國家藥監(jiān)局印發(fā)《關(guān)于開展醫(yī)療器械質(zhì)量安全風(fēng)險(xiǎn)隱患排查治理工作的通知》，明確將包括醫(yī)用口罩在內(nèi)的疫情防控類醫(yī)療器械作為第一項(xiàng)排查整治重點(diǎn)，要求各地做到風(fēng)險(xiǎn)隱患全面排查、治理責(zé)任全面落實(shí)、管理水平全面提升、質(zhì)量保障全面加強(qiáng)。截至10月底，各省藥監(jiān)局在醫(yī)療器械風(fēng)險(xiǎn)隱患排查治理中共計(jì)排查疫情防控醫(yī)療器械生產(chǎn)企業(yè)8304家，出動(dòng)檢查22400人次，監(jiān)督檢查8674家次，責(zé)令停產(chǎn)145家，立案處罰299家。

　　此外，國家藥監(jiān)局強(qiáng)化防疫類醫(yī)療器械專項(xiàng)抽檢，抽檢醫(yī)用口罩153批。各省藥監(jiān)局制定省級(jí)抽檢計(jì)劃，重點(diǎn)關(guān)注醫(yī)用口罩等疫情防控類醫(yī)療器械的質(zhì)量狀況，做到應(yīng)抽盡抽，同時(shí)，加大飛行檢查力度，堅(jiān)持問題導(dǎo)向，強(qiáng)化靶向精準(zhǔn)監(jiān)管，始終將醫(yī)用口罩等疫情防控醫(yī)療器械列為飛行檢查重點(diǎn)品種，各省藥監(jiān)局也將醫(yī)用口罩列為重點(diǎn)品種，組織開展省級(jí)飛行檢查。從總體上看，我國醫(yī)用口罩質(zhì)量狀況持續(xù)良好。

　　下一步，國家藥監(jiān)局將加大對(duì)新修訂的《醫(yī)療器械監(jiān)督管理?xiàng)l例》的宣貫力度，加強(qiáng)對(duì)醫(yī)用口罩等疫情防控醫(yī)療器械生產(chǎn)企業(yè)法定代表人等“關(guān)鍵少數(shù)”的培訓(xùn)，強(qiáng)化企業(yè)的法治意識(shí)、責(zé)任意識(shí)、風(fēng)險(xiǎn)意識(shí)、合規(guī)意識(shí)和自律意識(shí)，持續(xù)加強(qiáng)質(zhì)量管理體系建設(shè)，進(jìn)一步提升企業(yè)風(fēng)險(xiǎn)防控能力；強(qiáng)化風(fēng)險(xiǎn)隱患排查化解，指導(dǎo)督促各省級(jí)藥品監(jiān)督管理部門整治苗頭性、傾向性問題，嚴(yán)格落實(shí)違法行為“處罰到人”的要求，督促企業(yè)依法生產(chǎn)經(jīng)營；繼續(xù)將醫(yī)用口罩等疫情防控醫(yī)療器械列入飛行檢查的重點(diǎn)品種，通過組織開展飛行檢查，督促相關(guān)省級(jí)藥品監(jiān)督管理部門持續(xù)做好疫情防控醫(yī)療器械監(jiān)管工作，督促生產(chǎn)企業(yè)不斷提升產(chǎn)品質(zhì)量安全管理水平，切實(shí)保障疫情防控醫(yī)療器械產(chǎn)品質(zhì)量安全。