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【問】我(wo)公(gong)司想申報注冊(ce)一(yi)款II類(lei)低(di)強度(du)的超(chao)聲治療儀，但是(shi)關于這個(ge)產(chan)品我(wo)們想知道(dao)作為生產(chan)企業(ye)必須應具備(bei)哪些(xie)硬件條件？比(bi)如(ru)至少應能自檢(jian)(jian)(jian)/開展(zhan)哪些(xie)試驗？我(wo)查(cha)到(dao)，出廠檢(jian)(jian)(jian)應至少包含輸出功率的準(zhun)確性(xing)檢(jian)(jian)(jian)驗，還有其他的嗎？

【答】關(guan)于您咨詢(xun)的(de)(de)(de)(de)(de)(de)(de)問題，經核實回復如下(xia)：1、關(guan)于“生(sheng)產(chan)(chan)(chan)(chan)企業(ye)必(bi)須應(ying)具備(bei)(bei)哪些(xie)硬件條(tiao)件”：參(can)照(zhao)《醫(yi)療(liao)(liao)器(qi)(qi)(qi)械生(sheng)產(chan)(chan)(chan)(chan)監督(du)管理辦法（2022年3月10日(ri)國家市場監督(du)管理總局令第(di)53號(hao)公布(bu) 自2022年5月1日(ri)起施(shi)行(xing)(xing)）》的(de)(de)(de)(de)(de)(de)(de)第(di)九條(tiao)執行(xing)(xing)：第(di)九條(tiao) 從事醫(yi)療(liao)(liao)器(qi)(qi)(qi)械生(sheng)產(chan)(chan)(chan)(chan)活動，應(ying)當具備(bei)(bei)下(xia)列條(tiao)件：（一）有(you)與(yu)生(sheng)產(chan)(chan)(chan)(chan)的(de)(de)(de)(de)(de)(de)(de)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械相適應(ying)的(de)(de)(de)(de)(de)(de)(de)生(sheng)產(chan)(chan)(chan)(chan)場地、環境條(tiao)件、生(sheng)產(chan)(chan)(chan)(chan)設(she)備(bei)(bei)以(yi)(yi)(yi)及(ji)(ji)(ji)專(zhuan)(zhuan)業(ye)技(ji)術人員；（二(er)）有(you)能對生(sheng)產(chan)(chan)(chan)(chan)的(de)(de)(de)(de)(de)(de)(de)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械進行(xing)(xing)質(zhi)量(liang)檢(jian)(jian)驗(yan)(yan)(yan)(yan)的(de)(de)(de)(de)(de)(de)(de)機(ji)構或(huo)(huo)者(zhe)專(zhuan)(zhuan)職檢(jian)(jian)驗(yan)(yan)(yan)(yan)人員以(yi)(yi)(yi)及(ji)(ji)(ji)檢(jian)(jian)驗(yan)(yan)(yan)(yan)設(she)備(bei)(bei)；（三(san)）有(you)保證(zheng)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械質(zhi)量(liang)的(de)(de)(de)(de)(de)(de)(de)管理制(zhi)(zhi)度；（四）有(you)與(yu)生(sheng)產(chan)(chan)(chan)(chan)的(de)(de)(de)(de)(de)(de)(de)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械相適應(ying)的(de)(de)(de)(de)(de)(de)(de)售(shou)后服務能力；（五）符合(he)產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)研制(zhi)(zhi)、生(sheng)產(chan)(chan)(chan)(chan)工藝(yi)文件規(gui)定的(de)(de)(de)(de)(de)(de)(de)要(yao)(yao)(yao)求(qiu)(qiu)。2、關(guan)于出(chu)廠檢(jian)(jian)驗(yan)(yan)(yan)(yan)條(tiao)款要(yao)(yao)(yao)求(qiu)(qiu)，需結(jie)合(he)產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)特點(dian)和性能指標，在《產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)技(ji)術要(yao)(yao)(yao)求(qiu)(qiu)》的(de)(de)(de)(de)(de)(de)(de)基礎上(shang)制(zhi)(zhi)定《成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)》等文件，并在實際中實施(shi)。相關(guan)參(can)考性依據如下(xia)：（1）《醫(yi)療(liao)(liao)器(qi)(qi)(qi)械生(sheng)產(chan)(chan)(chan)(chan)質(zhi)量(liang)管理規(gui)范(fan)現場檢(jian)(jian)查指導原則》 *8.3.1應(ying)當根據強(qiang)制(zhi)(zhi)性標準(zhun)以(yi)(yi)(yi)及(ji)(ji)(ji)經注冊或(huo)(huo)者(zhe)備(bei)(bei)案(an)的(de)(de)(de)(de)(de)(de)(de)產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)技(ji)術要(yao)(yao)(yao)求(qiu)(qiu)制(zhi)(zhi)定產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)的(de)(de)(de)(de)(de)(de)(de)檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)，并出(chu)具相應(ying)的(de)(de)(de)(de)(de)(de)(de)檢(jian)(jian)驗(yan)(yan)(yan)(yan)報(bao)告或(huo)(huo)證(zheng)書。【查看產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)是(shi)否(fou)涵蓋強(qiang)制(zhi)(zhi)性標準(zhun)以(yi)(yi)(yi)及(ji)(ji)(ji)經注冊或(huo)(huo)者(zhe)備(bei)(bei)案(an)的(de)(de)(de)(de)(de)(de)(de)產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)技(ji)術要(yao)(yao)(yao)求(qiu)(qiu)的(de)(de)(de)(de)(de)(de)(de)性能指標；確認檢(jian)(jian)驗(yan)(yan)(yan)(yan)記錄是(shi)否(fou)能夠(gou)證(zheng)實產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)符合(he)要(yao)(yao)(yao)求(qiu)(qiu)；查看是(shi)否(fou)根據檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)及(ji)(ji)(ji)檢(jian)(jian)驗(yan)(yan)(yan)(yan)結(jie)果出(chu)具相應(ying)的(de)(de)(de)(de)(de)(de)(de)檢(jian)(jian)驗(yan)(yan)(yan)(yan)報(bao)告或(huo)(huo)證(zheng)書。】（2）《總局關(guan)于發布(bu)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械生(sheng)產(chan)(chan)(chan)(chan)企業(ye)質(zhi)量(liang)控(kong)(kong)制(zhi)(zhi)與(yu)成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)放(fang)(fang)行(xing)(xing)指南的(de)(de)(de)(de)(de)(de)(de)通(tong)告（2016年第(di)173號(hao)）》 二(er)、質(zhi)量(liang)控(kong)(kong)制(zhi)(zhi)與(yu)成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)放(fang)(fang)行(xing)(xing)（三(san)）成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)檢(jian)(jian)驗(yan)(yan)(yan)(yan)與(yu)成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)放(fang)(fang)行(xing)(xing) .成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)的(de)(de)(de)(de)(de)(de)(de)內容原則上(shang)應(ying)當覆蓋已注冊或(huo)(huo)者(zhe)備(bei)(bei)案(an)的(de)(de)(de)(de)(de)(de)(de)產(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)技(ji)術要(yao)(yao)(yao)求(qiu)(qiu)中需要(yao)(yao)(yao)常規(gui)控(kong)(kong)制(zhi)(zhi)的(de)(de)(de)(de)(de)(de)(de)檢(jian)(jian)驗(yan)(yan)(yan)(yan)項目和檢(jian)(jian)驗(yan)(yan)(yan)(yan)方法。不能覆蓋的(de)(de)(de)(de)(de)(de)(de)，應(ying)當在成(cheng)(cheng)(cheng)(cheng)品(pin)(pin)(pin)(pin)檢(jian)(jian)驗(yan)(yan)(yan)(yan)規(gui)程(cheng)(cheng)(cheng)中予以(yi)(yi)(yi)說明。必(bi)要(yao)(yao)(yao)時(shi)，應(ying)當給出(chu)經過確認的(de)(de)(de)(de)(de)(de)(de)替代解決方案(an)。 另(ling)外：為更便捷溝(gou)通(tong)，企業(ye)也可以(yi)(yi)(yi)通(tong)過“北京(jing)器(qi)(qi)(qi)審咨詢(xun)和預約系統”進行(xing)(xing)醫(yi)療(liao)(liao)器(qi)(qi)(qi)械注冊相關(guan)的(de)(de)(de)(de)(de)(de)(de)問題溝(gou)通(tong)。溝(gou)通(tong)方式(shi)可采用(yong)“線上(shang)文字提問”或(huo)(huo)“受理前現場咨詢(xun)”。

本文由廣州(zhou)佳譽醫(yi)療器械有限公司/佛山(shan)浩揚醫(yi)療器械有限公司聯合編輯