法定實施機關：湖北(bei)省食品藥品監督管理局
編號：09-665-3
法律法規依據：
1.《醫療(liao)器(qi)(qi)械(xie)監督管理條例》第十九條 醫療(liao)器(qi)(qi)械(xie)生(sheng)(sheng)產企業(ye)(ye)應當符(fu)合下列條件：(一(yi))具(ju)有(you)(you)與(yu)其(qi)(qi)生(sheng)(sheng)產的(de)醫療(liao)器(qi)(qi)械(xie)相(xiang)適(shi)應的(de)專業(ye)(ye)技術人員(yuan)；(二)具(ju)有(you)(you)與(yu)其(qi)(qi)生(sheng)(sheng)產的(de)醫療(liao)器(qi)(qi)械(xie)相(xiang)適(shi)應的(de)生(sheng)(sheng)產場地及環境(jing)；(三)具(ju) 有(you)(you)與(yu)其(qi)(qi)生(sheng)(sheng)產的(de)醫療(liao)器(qi)(qi)械(xie)相(xiang)適(shi)應的(de)生(sheng)(sheng)產設備(bei)(bei)；(四)具(ju)有(you)(you)對其(qi)(qi)生(sheng)(sheng)產的(de)醫療(liao)器(qi)(qi)械(xie)產品進行質量(liang)檢驗的(de)機(ji)構或者(zhe)人員(yuan)及檢驗設備(bei)(bei)；
2.《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)監督管理(li)(li)(li)(li)辦(ban)(ban)法(fa)》（局令第(di)12號）第(di)十(shi)(shi)七(qi)條 《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)分為(wei)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)和(he)登(deng)(deng)記(ji)(ji)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)。許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)是 指(zhi)法(fa)定(ding)(ding)代表(biao)(biao)人、企(qi)(qi)(qi)(qi)業(ye)負責人、注冊(ce)地址、生(sheng)(sheng)產(chan)(chan)(chan)地址、生(sheng)(sheng)產(chan)(chan)(chan)范圍的(de)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)。登(deng)(deng)記(ji)(ji)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)是指(zhi)除上(shang)述事(shi)(shi)(shi)項(xiang)(xiang)(xiang)以外(wai)的(de)其他事(shi)(shi)(shi)項(xiang)(xiang)(xiang)的(de)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)。第(di)十(shi)(shi)八條 醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke) 事(shi)(shi)(shi)項(xiang)(xiang)(xiang)的(de)，應(ying)(ying)當在原許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)發(fa)(fa)生(sheng)(sheng)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)30日(ri)前(qian)，填寫《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)（變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)）申(shen)(shen)(shen)請(qing)(qing)表(biao)(biao)》，參照本辦(ban)(ban)法(fa)第(di)九條的(de)規(gui)定(ding)(ding)提交(jiao)涉及(ji)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)內容的(de)有關(guan)(guan)材(cai)(cai)料(liao)，向原發(fa)(fa) 證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)機(ji)關(guan)(guan)申(shen)(shen)(shen)請(qing)(qing)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)登(deng)(deng)記(ji)(ji)。原發(fa)(fa)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)機(ji)關(guan)(guan)應(ying)(ying)當自收(shou)(shou)到(dao)企(qi)(qi)(qi)(qi)業(ye)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)申(shen)(shen)(shen)請(qing)(qing)和(he)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)申(shen)(shen)(shen)請(qing)(qing)材(cai)(cai)料(liao)之日(ri)起15個(ge)工作(zuo)日(ri)內作(zuo)出(chu)準(zhun)予(yu)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)或(huo)者不(bu)予(yu)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)的(de)決定(ding)(ding)。 準(zhun)予(yu)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)的(de)，收(shou)(shou)回原證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)，換發(fa)(fa)新(xin)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)，變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)后(hou)(hou)的(de)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》有效(xiao)期(qi)的(de)截止(zhi)日(ri)期(qi)不(bu)變(bian)(bian)(bian)。不(bu)予(yu)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)的(de)，應(ying)(ying)當書面(mian)說(shuo)明理(li)(li)(li)(li)由，并告知(zhi)申(shen)(shen)(shen)請(qing)(qing)人享有依法(fa)申(shen)(shen)(shen)請(qing)(qing)行 政(zheng)(zheng)復(fu)議或(huo)者提起行政(zheng)(zheng)訴(su)訟的(de)權利。醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)依法(fa)辦(ban)(ban)理(li)(li)(li)(li)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)的(de)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)手續后(hou)(hou)，應(ying)(ying)當及(ji)時向工商行政(zheng)(zheng)管理(li)(li)(li)(li)部門(men)辦(ban)(ban)理(li)(li)(li)(li)企(qi)(qi)(qi)(qi)業(ye)注冊(ce)登(deng)(deng)記(ji)(ji) 的(de)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)手續。第(di)十(shi)(shi)九條 醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》登(deng)(deng)記(ji)(ji)事(shi)(shi)(shi)項(xiang)(xiang)(xiang)的(de)，應(ying)(ying)當在工商行政(zheng)(zheng)管理(li)(li)(li)(li)部門(men)核準(zhun)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)后(hou)(hou)30日(ri)內，填寫《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye) 許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)（變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)）申(shen)(shen)(shen)請(qing)(qing)表(biao)(biao)》，向原發(fa)(fa)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)機(ji)關(guan)(guan)申(shen)(shen)(shen)請(qing)(qing)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)登(deng)(deng)記(ji)(ji)。原發(fa)(fa)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)機(ji)關(guan)(guan)應(ying)(ying)當自收(shou)(shou)到(dao)企(qi)(qi)(qi)(qi)業(ye)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)申(shen)(shen)(shen)請(qing)(qing)和(he)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)申(shen)(shen)(shen)請(qing)(qing)材(cai)(cai)料(liao)之日(ri)起15個(ge)工作(zuo)日(ri)內為(wei) 其辦(ban)(ban)理(li)(li)(li)(li)變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)手續。符合規(gui)定(ding)(ding)的(de)，收(shou)(shou)回原證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)，換發(fa)(fa)新(xin)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng),變(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)(geng)(geng)后(hou)(hou)的(de)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》有效(xiao)期(qi)的(de)截止(zhi)日(ri)期(qi)不(bu)變(bian)(bian)(bian)。第(di)二(er)十(shi)(shi)條 第(di)二(er)類(lei)、第(di)三類(lei)醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye) 合并、分立或(huo)者跨(kua)原管轄地遷移的(de)，應(ying)(ying)當按照本辦(ban)(ban)法(fa)第(di)七(qi)條至(zhi)第(di)九條的(de)規(gui)定(ding)(ding)重新(xin)辦(ban)(ban)理(li)(li)(li)(li)《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)(qi)(qi)業(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)》。
3.《湖北省組(zu)(zu)織(zhi)機(ji)構(gou)(gou)代(dai)碼管理辦(ban)法(fa)》（湖北省令第(di)328號）第(di)五條 本(ben)省行(xing)(xing)政區(qu)域內依(yi)法(fa)成(cheng)立(li)的(de)機(ji)關、企業(ye)、事業(ye)單位、社會團體以及其(qi)他組(zu)(zu)織(zhi)機(ji)構(gou)(gou)，應當按(an)照本(ben)辦(ban)法(fa)的(de)規定(ding)辦(ban)理組(zu)(zu)織(zhi)機(ji)構(gou)(gou)代(dai)碼登記，并領(ling)取組(zu)(zu)織(zhi)機(ji)構(gou)(gou)代(dai)碼證書。第(di)六(liu)條 稅務、統(tong)計、工(gong)商(shang)行(xing)(xing)政管理……等部門(men)或機(ji)構(gou)(gou)在有關業(ye)務活動中，應當應用(yong)和查驗組(zu)(zu)織(zhi)機(ji)構(gou)(gou)代(dai)碼。
審批范圍和條件：
1．湖北省(sheng)行政區域內(nei)持有《醫療(liao)器(qi)械生(sheng)產企(qi)業許可證》的生(sheng)產企(qi)業在(zai)有效期內(nei)申(shen)請變更生(sheng)產地址、生(sheng)產范圍等許可事項；
2．符合《醫療(liao)器械監督管(guan)理條(tiao)例》等(deng)變(bian)更《醫療(liao)器械生產(chan)企業(ye)許可(ke)證》生產(chan)地址、生產(chan)范圍的相關(guan)規定。
申請材料：
（一）凡是變更事項(xiang)需(xu)提交以下材料：
1.企業申請報告；
2.《醫療器械生產企業許可證（變更）申請表》一式(shi)三(san)份；
3.《醫療器(qi)械生產企業許可證(zheng)》正、副本原件及復印件；
4.工商(shang)部門《營業執照》復印件，《組(zu)織機構代碼證書(shu)》復印件；
5.相關變更(geng)內容的證明(ming)材料(liao)；
6.企(qi)業所(suo)在(zai)地食品(pin)(pin)(pin)藥(yao)品(pin)(pin)(pin)監(jian)督管(guan)理局(ju)提供的沒有因違(wei)法經營被食品(pin)(pin)(pin)藥(yao)品(pin)(pin)(pin)監(jian)督管(guan)理局(ju)立案(an)調查尚未(wei)結案(an)，或已做出行(xing)政處罰決定尚未(wei)履行(xing)處罰的有關證明；
7.申報材(cai)料(liao)真(zhen)實性承諾書。
凡申(shen)請(qing)企(qi)業申(shen)報材料(liao)時(shi)，辦(ban)理人(ren)員人(ren)不是法定代表人(ren)或負責人(ren)本人(ren)，企(qi)業應當提(ti)交《授權委托(tuo)書》1份。
（二）變更生產地址另補充以下(xia)材料(liao)：
1.生(sheng)產(chan)(chan)場地證(zheng)明（產(chan)(chan)權(quan)證(zheng)或租賃協議(yi)復印件(jian)(jian)，并(bing)交(jiao)驗原件(jian)(jian)。提交(jiao)租賃協議(yi)時，應提供出租方的產(chan)(chan)權(quan)證(zheng)復印件(jian)(jian)，并(bing)交(jiao)驗原件(jian)(jian)）；
2.廠區總平面(mian)圖，主要生(sheng)產車間布置圖。有潔凈要求的車間,須(xu)標明功能間及人(ren)物流走向。
3.擬生產(chan)產(chan)品的工藝(yi)流程圖(tu)，并注明(ming)主要控制項目和控制點。包括關(guan)鍵和特殊工序的設備(bei)、人員(yuan)、及(ji)工藝(yi)參數控制的說(shuo)明(ming)；
（三）變更生(sheng)產(chan)范圍另補(bu)充以下材(cai)料：
1.主要生(sheng)產設備及檢驗儀器清單；
2.生(sheng)(sheng)產質量管理規范(fan)文件目錄：（包括采(cai)購、驗收(shou)、生(sheng)(sheng)產過(guo)程、產品驗收(shou)、入庫、出庫、質量跟蹤、用戶反饋、不良(liang)事(shi)件檢測(ce)和質量事(shi)故(gu)報告制度等文件、企業(ye)組織機構圖(tu)）；
3.擬生產(chan)產(chan)品(pin)的(de)(de)工藝流程圖，并注明(ming)主要控(kong)(kong)制(zhi)項目(mu)和(he)控(kong)(kong)制(zhi)點。包括關鍵和(he)特殊工序的(de)(de)設(she)備、人員、及工藝參數控(kong)(kong)制(zhi)的(de)(de)說明(ming)；
4.主(zhu)要生(sheng)產設備及檢驗儀器清單；
5.擬生(sheng)產(chan)無菌(jun)醫療器(qi)械的(de),須提供潔凈車間(jian)合(he)(he)格(ge)檢測(ce)(ce)報告。由省級(ji)食品藥品監督管理部門認可(ke)的(de)檢測(ce)(ce)機(ji)構出(chu)具的(de)一(yi)年內的(de)符合(he)(he)《無菌(jun)醫療器(qi)械器(qi)具生(sheng)產(chan)管理規范》(YY0033)的(de)合(he)(he)格(ge)檢測(ce)(ce)報告。
申(shen)報(bao)材(cai)(cai)料一式1份，應(ying)清晰、完(wan)整，統(tong)一用A4紙張(zhang)打印(yin)或(huo)復印(yin)，法(fa)定(ding)代表人簽字(zi)并逐份加(jia)蓋企業公(gong)章，按照申(shen)請材(cai)(cai)料目錄裝訂(ding)成冊(ce)。
辦理流程：
1、局行政審批服務中心受理(li)、初審；
2、需現場考核的由局審(shen)(shen)評認證中心(xin)進行技術審(shen)(shen)查(cha)；
3、醫療器械處或直(zhi)屬(shu)分局(ju)（直(zhi)管(guan)企業由直(zhi)屬(shu)分局(ju)負責）根據(ju)局(ju)審(shen)評認證中心意(yi)見結合審(shen)核，符合要求的，呈分管(guan)局(ju)長審(shen)定(ding)批準；
4、局行(xing)政審批(pi)服務中心告知申(shen)請人，制發、送達變更后的(de)《醫療器械生產企業許可證》正(zheng)副本或審批(pi)意見。
辦理期限：
法(fa)定(ding)審批時(shi)限為15個(ge)工(gong)作日(ri)，承諾辦(ban)理期限10個(ge)工(gong)作日(ri)。辦(ban)理期限不包括申請人補正材料、技術審查（45個(ge)工(gong)作日(ri)），頒發(fa)、送達許可證(zheng)件（10個(ge)工(gong)作日(ri)）所需時(shi)間，特殊(shu)情況可延長(chang)10個(ge)工(gong)作日(ri)。
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申請表格名稱及(ji)獲取(qu)方式(shi)：
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所有申請表格均(jun)可在(zai)省食品藥品監督管理局門戶網站下載
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受理地點：武漢市東湖路136號(hao)湖北(bei)省食品(pin)藥品(pin)監(jian)督管理局行(xing)政審(shen)批服務中心(xin)
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