法定(ding)實(shi)施機關：湖北省(sheng)食品藥品監督管理局(ju)
編號：09-665-4
法律法規依據：
1.《醫療(liao)器械監督管理條例》第十九條；
2.《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)監督管(guan)理辦(ban)法(fa)》（國家食品藥品監督管(guan)理局令第(di)(di)(di)12號）。第(di)(di)(di)十七條(tiao)(tiao) 《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)分為許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)和(he)登(deng)(deng)(deng)記(ji)事(shi)(shi)(shi) 項(xiang)(xiang)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)。許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)是指(zhi)法(fa)定(ding)(ding)代表人(ren)、企(qi)(qi)業(ye)(ye)負責人(ren)、注冊(ce)地(di)址(zhi)、生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)地(di)址(zhi)、生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)范圍的(de)(de)(de)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)。登(deng)(deng)(deng)記(ji)事(shi)(shi)(shi)項(xiang)(xiang)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)是指(zhi)除上述事(shi)(shi)(shi)項(xiang)(xiang)以外的(de)(de)(de)其他事(shi)(shi)(shi)項(xiang)(xiang)的(de)(de)(de)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)。第(di)(di)(di)十八條(tiao)(tiao) 醫(yi) 療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)的(de)(de)(de)，應(ying)(ying)當(dang)(dang)在原(yuan)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)發(fa)生(sheng)(sheng)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)30日(ri)(ri)(ri)前(qian)，填寫《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)（變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)）申(shen)請(qing)(qing)表》，參照本辦(ban)法(fa)第(di)(di)(di)九條(tiao)(tiao)的(de)(de)(de)規(gui)定(ding)(ding)提(ti)交涉及(ji)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng) 內(nei)容的(de)(de)(de)有(you)關(guan)(guan)材料，向原(yuan)發(fa)證(zheng)(zheng)(zheng)(zheng)機關(guan)(guan)申(shen)請(qing)(qing)《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)登(deng)(deng)(deng)記(ji)。原(yuan)發(fa)證(zheng)(zheng)(zheng)(zheng)機關(guan)(guan)應(ying)(ying)當(dang)(dang)自(zi)收到(dao)企(qi)(qi)業(ye)(ye)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)申(shen)請(qing)(qing)和(he)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)申(shen)請(qing)(qing)材料之日(ri)(ri)(ri)起(qi)15個(ge)工(gong)作日(ri)(ri)(ri)內(nei)作出準予(yu)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian) 更(geng)(geng)(geng)(geng)(geng)或者(zhe)不予(yu)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)的(de)(de)(de)決定(ding)(ding)。準予(yu)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)的(de)(de)(de)，收回原(yuan)證(zheng)(zheng)(zheng)(zheng)，換發(fa)新證(zheng)(zheng)(zheng)(zheng)，變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)后的(de)(de)(de)《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》有(you)效期的(de)(de)(de)截(jie)止日(ri)(ri)(ri)期不變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)。不予(yu)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)的(de)(de)(de)，應(ying)(ying)當(dang)(dang)書面說明理由(you)，并(bing)告 知申(shen)請(qing)(qing)人(ren)享有(you)依法(fa)申(shen)請(qing)(qing)行(xing)政(zheng)復議或者(zhe)提(ti)起(qi)行(xing)政(zheng)訴訟的(de)(de)(de)權利(li)。醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)依法(fa)辦(ban)理《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)事(shi)(shi)(shi)項(xiang)(xiang)的(de)(de)(de)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)手(shou)續后，應(ying)(ying)當(dang)(dang)及(ji)時向工(gong)商行(xing)政(zheng)管(guan) 理部(bu)門辦(ban)理企(qi)(qi)業(ye)(ye)注冊(ce)登(deng)(deng)(deng)記(ji)的(de)(de)(de)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)手(shou)續。第(di)(di)(di)十九條(tiao)(tiao) 醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》登(deng)(deng)(deng)記(ji)事(shi)(shi)(shi)項(xiang)(xiang)的(de)(de)(de)，應(ying)(ying)當(dang)(dang)在工(gong)商行(xing)政(zheng)管(guan)理部(bu)門核(he)準變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)后30日(ri)(ri)(ri)內(nei)， 填寫《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)（變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)）申(shen)請(qing)(qing)表》，向原(yuan)發(fa)證(zheng)(zheng)(zheng)(zheng)機關(guan)(guan)申(shen)請(qing)(qing)《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)登(deng)(deng)(deng)記(ji)。原(yuan)發(fa)證(zheng)(zheng)(zheng)(zheng)機關(guan)(guan)應(ying)(ying)當(dang)(dang)自(zi)收到(dao)企(qi)(qi)業(ye)(ye)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)申(shen)請(qing)(qing)和(he)變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)申(shen)請(qing)(qing)材料 之日(ri)(ri)(ri)起(qi)15個(ge)工(gong)作日(ri)(ri)(ri)內(nei)為其辦(ban)理變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)手(shou)續。符合(he)規(gui)定(ding)(ding)的(de)(de)(de)，收回原(yuan)證(zheng)(zheng)(zheng)(zheng)，換發(fa)新證(zheng)(zheng)(zheng)(zheng),變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)更(geng)(geng)(geng)(geng)(geng)后的(de)(de)(de)《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》有(you)效期的(de)(de)(de)截(jie)止日(ri)(ri)(ri)期不變(bian)(bian)(bian)(bian)(bian)(bian)(bian)(bian)。第(di)(di)(di)二(er)(er)十條(tiao)(tiao) 第(di)(di)(di)二(er)(er)類、 第(di)(di)(di)三類醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)合(he)并(bing)、分立或者(zhe)跨(kua)原(yuan)管(guan)轄地(di)遷移的(de)(de)(de)，應(ying)(ying)當(dang)(dang)按照本辦(ban)法(fa)第(di)(di)(di)七條(tiao)(tiao)至(zhi)第(di)(di)(di)九條(tiao)(tiao)的(de)(de)(de)規(gui)定(ding)(ding)重新辦(ban)理《醫(yi)療(liao)(liao)(liao)器(qi)械(xie)(xie)(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)許(xu)(xu)(xu)(xu)可(ke)(ke)(ke)證(zheng)(zheng)(zheng)(zheng)》；
3.《湖北省(sheng)組(zu)織(zhi)機(ji)(ji)構(gou)代(dai)碼(ma)管理辦(ban)法(fa)》（湖北省(sheng)令第(di)328號(hao)）第(di)五條 本省(sheng)行(xing)政區(qu)域內依法(fa)成立的(de)機(ji)(ji)關(guan)、企業(ye)、事業(ye)單位、社會(hui)團體以及其(qi)他組(zu)織(zhi)機(ji)(ji)構(gou)，應(ying)當按照本辦(ban)法(fa)的(de)規定辦(ban)理組(zu)織(zhi)機(ji)(ji)構(gou)代(dai)碼(ma)登(deng)記(ji)，并領取組(zu)織(zhi)機(ji)(ji)構(gou)代(dai)碼(ma)證書。第(di)六條 稅(shui)務、統計、工商行(xing)政管理……等部(bu)門(men)或機(ji)(ji)構(gou)在有關(guan)業(ye)務活動中(zhong)，應(ying)當應(ying)用和查驗組(zu)織(zhi)機(ji)(ji)構(gou)代(dai)碼(ma)。
審批范圍和條件：
1.湖北(bei)省行(xing)政區域內(nei)持(chi)有《器(qi)械生(sheng)產許可(ke)證》的生(sheng)產企(qi)(qi)業在(zai)有效期內(nei)申請變(bian)更(geng)企(qi)(qi)業名稱、法定代表人等登(deng)記事(shi)項和許可(ke)事(shi)項；
2.符(fu)合(he)《醫療(liao)器械(xie)生產(chan)(chan)監督(du)管理辦法》等變(bian)更《醫療(liao)器械(xie)生產(chan)(chan)企業(ye)(ye)許可證》企業(ye)(ye)名稱、法定(ding)代表(biao)人、企業(ye)(ye)負責人、注冊地址的(de)相關規(gui)定(ding)。
申請材料：
1.企業申請報告；
2.醫(yi)療器械生(sheng)產企業許可證（變更）申請表》3份；
3.《醫療器械生(sheng)產企(qi)業許可(ke)證(zheng)》正本、副本的原(yuan)件及1份副本復印件；
4.相關變更證明材料和變更需補充(chong)材料：
（1）變(bian)(bian)更企(qi)業名稱(cheng)的，應提交：工商行政管理部門出具的《企(qi)業名稱(cheng)變(bian)(bian)更核準通知書(shu)(shu)》或已(yi)變(bian)(bian)更的《工商營業執照(zhao)》副本原件和 1 份(fen)復印件《組織機構代(dai)碼證書(shu)(shu)》復印件；
（2）變(bian)更企業法(fa)定代表人的(de)(de)(de)，應提交： 法(fa)定代表人的(de)(de)(de)身份(fen)(fen)證明(ming)，學歷證明(ming)或(huo)職(zhi)稱證明(ming)，任命(ming)文件的(de)(de)(de)復印件和(he)工作簡歷 1 份(fen)(fen)；已(yi)變(bian)更的(de)(de)(de)《工商營(ying)業執照》副(fu)本 1 份(fen)(fen)復印件；
（3）變更企業(ye)負(fu)責人(ren)(ren)的，還應提交： 企業(ye)負(fu)責人(ren)(ren)的身份(fen)證明，學(xue)歷證明或(huo)職稱證明，任命文件的復印件和(he)工作簡歷 1 份(fen)；
（4）變更企業注冊地(di)(di)址(zhi)(zhi)（不含生產(chan)地(di)(di)址(zhi)(zhi)）的(de)，還應(ying)提交：《工商營業執(zhi)照》副(fu)本原件和 1 份復印件；
5.申報材(cai)料真實性承(cheng)諾書；
6.企(qi)業申報材料時，經辦人(ren)不是法(fa)定代(dai)表(biao)人(ren)或負責人(ren)本人(ren)，企(qi)業應當提交《法(fa)定代(dai)表(biao)人(ren)授(shou)權委托書(shu)》1份(fen)；
7.省(sheng)食(shi)品藥(yao)品監(jian)督(du)管(guan)(guan)理(li)局(ju)直(zhi)屬分局(ju)負責(ze)直(zhi)管(guan)(guan)企(qi)(qi)(qi)(qi)(qi)(qi)業變(bian)更(geng)。省(sheng)食(shi)品藥(yao)品監(jian)督(du)管(guan)(guan)理(li)局(ju)委托市（州）級食(shi)品藥(yao)品監(jian)督(du)管(guan)(guan)理(li)局(ju)負責(ze)企(qi)(qi)(qi)(qi)(qi)(qi)業名稱、企(qi)(qi)(qi)(qi)(qi)(qi)業注冊地址、企(qi)(qi)(qi)(qi)(qi)(qi)業 法定代(dai)表(biao)(biao)人(ren)(ren)(ren)(ren)、企(qi)(qi)(qi)(qi)(qi)(qi)業負責(ze)人(ren)(ren)(ren)(ren)、企(qi)(qi)(qi)(qi)(qi)(qi)業質量管(guan)(guan)理(li)人(ren)(ren)(ren)(ren)變(bian)更(geng)事項。企(qi)(qi)(qi)(qi)(qi)(qi)業同時(shi)(shi)變(bian)更(geng)企(qi)(qi)(qi)(qi)(qi)(qi)業法定代(dai)表(biao)(biao)人(ren)(ren)(ren)(ren)、企(qi)(qi)(qi)(qi)(qi)(qi)業負責(ze)人(ren)(ren)(ren)(ren)、企(qi)(qi)(qi)(qi)(qi)(qi)業質量管(guan)(guan)理(li)人(ren)(ren)(ren)(ren)時(shi)(shi)需在省(sheng)食(shi)品藥(yao)品監(jian)督(du)管(guan)(guan)理(li)局(ju)申請變(bian)更(geng)。
凡申(shen)請材料需提交(jiao)復印(yin)件(jian)的，申(shen)請人(ren)須(xu)在復印(yin)件(jian)上注明“此(ci)復印(yin)件(jian)與原件(jian)相符(fu)”字樣(yang)或者(zhe)文字說明，注明日期(qi)，加蓋單位公章(zhang)(zhang)；個人(ren)申(shen)請的須(xu)簽字或簽章(zhang)(zhang)。
申(shen)請(qing)材(cai)料應完整、清晰、簽字，并逐份加蓋(gai)公章，所有(you)(you)申(shen)請(qing)表(biao)格電腦打(da)字填寫，所有(you)(you)材(cai)料統(tong)一(yi)用A4紙打(da)印或復印，按照申(shen)請(qing)材(cai)料目錄順序裝訂成冊(ce)。
辦理流程：
直管企業(ye)單個事項變更辦理(li)流程：
1、局(ju)行政審(shen)(shen)批(pi)服務中心(xin)受(shou)理、初審(shen)(shen)；
2、局直屬分(fen)局綜合審(shen)核，符合要(yao)求的，呈分(fen)局局長審(shen)批(pi)；
3、局行政(zheng)審(shen)(shen)批(pi)服務中心告知申(shen)請人(ren)，核發、送達(da)變更后的《醫療(liao)器(qi)械(xie)生產企業許可證》正副本或(huo)審(shen)(shen)批(pi)意見(jian)。
同時(shi)變更企(qi)(qi)(qi)業(ye)法定代(dai)表(biao)人、企(qi)(qi)(qi)業(ye)負責人、企(qi)(qi)(qi)業(ye)質量負責人需要技術(shu)審查，辦理(li)流程：
1、局行(xing)政審(shen)批服務中心受理、初審(shen)；
2、局(ju)藥品審(shen)評(ping)認證中心(xin)進(jin)行(xing)技(ji)術審(shen)查；
3、局(ju)醫療器械處或(huo)直屬分(fen)(fen)局(ju)（直管企業由直屬分(fen)(fen)局(ju)負責）綜(zong)合(he)審核，符合(he)要求的(de)，報(bao)醫療器械處處長(chang)或(huo)直屬分(fen)(fen)局(ju)局(ju)長(chang)審批；
4、 行政(zheng)審批服務中心告知申請人，核發、送達(da)變更(geng)后的(de)《醫療器械生產企(qi)業許可證》正(zheng)副本或(huo)審批意(yi)見。
辦理期限：
法定審(shen)(shen)批時(shi)限(xian)為15個(ge)(ge)工(gong)作(zuo)日，承諾(nuo)辦(ban)理期限(xian)10個(ge)(ge)工(gong)作(zuo)日。辦(ban)理期限(xian)不包括申請人補(bu)正(zheng)材料(liao)、技(ji)術(shu)審(shen)(shen)查（16個(ge)(ge)工(gong)作(zuo)日），頒發、送達(da)許可(ke)證件（10個(ge)(ge)工(gong)作(zuo)日）所需(xu)時(shi)間(jian)，特殊(shu)情(qing)況可(ke)延長10個(ge)(ge)工(gong)作(zuo)日。
收費(fei)依(yi)據和(he)標準： 不收費(fei)
申請表格名稱及獲(huo)取方式(shi)：
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所有申請表格均可(ke)在省(sheng)食(shi)品(pin)藥品(pin)監督管理(li)局門(men)戶網站下載
咨詢(xun)電話：（直屬分局）
投訴電話：027－87253808 027－87253889
受(shou)理地點：武漢市(shi)東(dong)湖路136號湖北(bei)省食品藥品監督管理局行政審(shen)批服務中心
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