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办理医疗器械经营企业许可证

shanghaishi

开办第二、三类医疗器械经营企业许可和变更事项申请

办理机构: 各区(县)食品药品监管分局
办理时间: 周二、周四 上午 9:00~11:00         下午13:00~16:00
电玩城平台注册 申办对象资格: 申请范围:   申请开办、许可、变更第二、三类医疗器械经营企业 开办条件:   (一)具有相应的经营场地及环境;   (二)具有相应的质量检验人员;   (三)具有对经营产品进行培训、维修等售后服务的能力;   (四)建立医疗器械质量管理制度;   (五)应收集并保存有关医疗器械的国家标准、行业标准。


办理程序:   (一)开办程序
   1、开办第二、三类医疗器械经营企业,应向经营所在地食品药品监管分局申请并提交以下资料:

  (1)《yiliaoqixiejingyingqiyekaibanxukegaozhichengnuoshu》;

  (2)gongshangxingzhengguanlibumenhefade《qiyemingchengyuxianhezhuntongzhishu》;

  (3)qiyefadingdaibiaorendeshenfenzheng(fuyinjian);

电玩城平台注册  (4)qitaxutigongdezhengmingwenjian。

  2、qu(xian)shipinyaopinjianguanfenjushoudaoshenqingrenchengnuoshuhexiangguanziliaohou,zai5gegongzuorineihefa《yiliaoqixiejingyingqiyekaibanxuketongzhi》,qiyepingkaibanxuketongzhixianggongshangxingzhengguanlibumenshenqing《yingyezhizhao》。

  shenqingjingyingfanweiwei“geleiyiliaoqixie”deqiye,yingxiangshishipinyaopinjianguanjutichushenqing。

  (er)xukechengxu:

  1、qiyeanzhao《shanghaishiyiliaoqixiejingyingqiyekaiban、xukezanxingguiding》wanchengqiyechoujianhou,yingxiangjingyingsuozaidishipinyaopinjianguanfenjushenling《yiliaoqixiejingyingqiyexukezheng》,bingtijiaoyixiaziliao:

  (1)《yiliaoqixiejingyingqiyexukezhengshenqingbiao》;

  (2)yingyezhizhao(jiagaiqiyegongzhangdefuyinjian);

电玩城平台注册  (3)qiyezhuyaoguanlirenyuandezigezhengmingwenjianhepeixunzhengming(fuyinjian);

  (4)jingying(cangchu)changdideyouguanzhengming:(chanquanzhenghuochuzufangdechanquanzhengjilinxieyidefuyinjian);

电玩城平台注册  (5)yiliaoqixiejingyingqiyezigerenketiaojianzichabiao;

电玩城平台注册  (6)qiyejingyingzhiliangguanlizhidumulu;

  (7)shufenzhijigoudeqiyebixutigongshangjigongsideyouguanzerenchengnuoshu;

  (8)qitaxutigongdezhengmingwenjian。

  2、qu(xian)shipinyaopinjianguanfenjushoudaoshenqingziliaohou,yingzai15gegongzuorineiwanchengziliaoshenchahexianchangshencha,zuochushenpijueding。duifuhetiaojianyaoqiuqiye,banfa《yiliaoqixiejingyingqiyexukezheng》;bufuhetiaojianyaoqiude,yingdangjiangbuyutongyideliyoushumiangaozhishenqingren。

电玩城平台注册  shenqingjingyingfanweiwei“geleiyiliaoqixie”qiye,youshishipinyaopinjianduguanlijuhuitongqiyejingyingsuozaidideshipinyaopinjianguanfenjushenpi,richangjianguanyougaifenjufuze。

  (san)biangengshenqing

  1、qiyebiangeng《yiliaoqixiejingyingqiyexukezheng》deyouguanneirong,yingxiangjingyingsuozaidishipinyaopinjianguanfenjushenqingbingtijiaoyixiaziliao:

  (1)《yiliaoqixiejingyingqiyebiangengshenqingbiao》;

  (2)《yiliaoqixiejingyingqiyexukezheng》zheng、fuben;

  (3)《yingyezhizhao》(fuyinjian);

电玩城平台注册  (4)xiangguanbiangengneirongdezhengmingcailiaoruxia:

电玩城平台注册  fadingdaibiaorenhuoqiyefuzerenbiangeng:tigongqiyezhuguanbumendepiwenhe/huodongshihuijueyi,biangenghoufadingdaibiaorenhuoqiyefuzerendeshenfenzhengjipeixunzhengming(fuyinjian)。

  qiyemingchengbiangeng:tigonggongshangguanlibumenhezhunde《qiyemingchengyuxianhezhuntongzhishu》fuyinjian。

  jingyingchangdibiangeng:tigongfangwuzulinxieyishuhe/huochanquanzheng。

  jingyingfanweibiangeng:qiyezhuyaoguanlirenyuandezigezhengmingwenjianhepeixunzhengming(fuyinjian),yiliaoqixiejingyingqiyezigerenketiaojianzichabiaojizhiliangguanlizhidumulu。

电玩城平台注册  (5)qitaxutigongdezhengmingwenjian。

  2、qu(xian)shipinyaopinjianguanfenjuzaishouliqiyefadingdaibiaoren、qiyefuzeren、qiyemingchengbiangengshenqingzhiriqi,5gegongzuorineizuochushenpijueding;qiyebiangengjingyingchangdi、jingyingfanweide,qu(xian)yaopinjianguanfenjuyingzaishoudaobiangengshenqingzhiriqi,10gegongzuorineizuzhixianchangshencha,bingzuochushenpijueding。

  申请变更经营范围为“各类医疗器械”企业,由市食品药品监督管理局会同企业经营所在地的食品药品监管分局审批,日常监管由该分局负责。

电玩城平台注册 收费标准及依据: 《医疗器械经营企业许可证》每户300元。


办理依据:

(yi)《yiliaoqixiejianduguanlitiaoli》guowuyuandi276haoling;   

(er)《yiliaoqixiejingyingqiyejianduguanlibanfa》guojiayaopinjianduguanlijudi19haoling;   

电玩城平台注册(san)zhongguoyiliaoqixiechanpinfenleimulu;   

(si)《shanghaishiyicixingshiyongwujunyiliaoqixiejianduguanliruoganguiding》shanghaishirenminzhengfudi5haoling;   

(wu)《yicixingshiyongwujunyiliaoqixiejianduguanlibanfa》guojiayaopinjianduguanlijudi24haoling;   

电玩城平台注册(liu)《yicixingshiyongwujunyiliaoqixiejingyingqiyezigerenkeshishixize(zanxing)》guoyaojianshi(2001)444hao;

(qi) 《shanghaishiyiliaoqixiejingyingqiyekaiban、xukezanxingguiding》 huyaojian(2002)650hao;   

电玩城平台注册(ba)《shanghaishiyiliaoqixiejingyingqiyexukezhengbiangengshenqingderuoganguiding》 huyaojian(2002)883hao;   

(jiu)《guanyutongyishouquyiliaoqixieshengchan、jingyingqiyexukezhengshenchafeidefuhan》shanghaishicaizhengju、wujiaju hucaizong(2000)46hao、hujiaxing(2000)158hao。

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