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深圳三类医疗器械许可证办理需要符合哪些条件

发布时间:2020-03-13 00:30 来源:未知 59次阅读

北京28登录SANLEIYILIAOQIXIEXUKEZHENGBIAOZHUNJIYUANCAILIAOMINGXI

YI、GONGZUORENYUANZHISHAOBIXUWUMING

1.ZHUYAOFUZEREN,DAXUEBENKEXUELI(YILIAOJIXIEYOUGUANJISHUZHUANYE:ZHIJIXIESHEBEI、GONGCHENGXIANGMU、DIANZIQIJIAN、YIYAOXUE、YAOLIXUE、HULIZHUANYE、WEISHENGWU、YOUJIHUAXUE、JIANCE、WULIXUE、DIANZIJISUANJI、SHUXUEKE、YUANCAILIAO、ZIDONGHUAJISHU、YAOYEMAOYI、YAOYEWANGLUOYINGXIAO、YAOYEXINXINEIRONGDENG),YAOCHUSHIXUELIZHENGSHUJISHENFENZHENGJIANZHENGBEN,WUNIANZUOYOUGONGZUOJINGLI。

2.PINZHIZERENRENDAXUEBENKEXUELI(LINCHUANGYIXUE:ZHILINCHUANGYIXUEZHUANYE(HANZHENLIAOJISHUZHUANYE)、ZHONGYIYAOXUE、ZHONGXIYIJISHUZHUANYE),YAOCHUSHIXUELIZHENGSHUJISHENFENZHENGJIANZHENGBEN,WUNIANZUOYOUGONGZUOJINGLI。

北京28登录3.PINZHIGUANLIRENYUANDAXUEBENKEXUELI(LINCHUANGYIXUE:ZHILINCHUANGYIXUEZHUANYE(HANZHENLIAOJISHUZHUANYE)、ZHONGYIYAOXUE、ZHONGXIYIJISHUZHUANYE),YAOCHUSHIXUELIZHENGSHUJISHENFENZHENGJIANZHENGBEN。

北京28登录4.GONGCHENGYANSHOUGONGZUORENYUAN(KEDANRENCANGCHUWULIUGONGZUORENYUAN、SHOUHOUWEIXIUFUWU)(ZHIGAOHUOPUTONGGAOZHONGBENKEYISHANGXUELI),YAOCHUSHIXUELIZHENGSHUJISHENFENZHENGJIANZHENGBEN。

北京28登录5.XIAOHUOGONGZUORENYUAN(KEDANRENJISUANJIWEIHU)JISUANJIZHUANYEZHIZAOXINGYEDAXUEBIYE,YAOCHUSHIXUELIZHENGSHUJISHENFENZHENGJIANZHENGBEN。

5BENRENWUBIZAIQIYEJIAOSHEBAO、QIANDINGHETONG(JIAOYINGYINJIANYANZHENGBEN),ANSHIZUOJISHUZHUANYELEIXUEXIPEIXUNBINGCHUSHIZHIBANDEKAOPINGKAOJUAN。

北京28登录5BENRENDETIJIANBAOGAODAN(BIXUDAOBENDIDESANJIJIADENGYIYUANZUOYUANGONGRUZHITIJIAN,DABANNIANNEIDE)

北京28登录KANCHANGSUOSHI5BENRENZAICHANG(BIXUDANGCHANGQIANMING、TANHUA)

ER、CHANGSUO:

北京28登录1、BANGONGCHANGDIZULINPINGJU(TAONEIJIANZHUMIANJIXUDUOYU80㎡)、ZULINXIEYI、PINGMIANSHEJITU;SHANGWUDASHAXIAOFANGSHEJISHENPIYIXIANGSHU、SHANGWUDASHAXIAOFANGGONGCHENGYANSHOUDABIAOYIXIANGSHU(YINGYINJIANXUGUANLIBANGAIZHANGGONGSIZHANG)。

北京28登录2、QIANSHUDISANFANGCANGCHUWULIUXIEYISHU,ZONGMIANJI≥40㎡,DISANFANGCHUSHIFANGWUSUOYOUQUANHUOSUOYOUQUANZHENGMINGCAILIAO、DITU、BIAOCHUZONGMIANJIDEPINGMIANSHEJITU、FANGJIANNEIFANGZHIPINGMIANSHEJITU。(RUWOCHANGCHUSHI,HANLENGLIANWULIU)

SAN、YILIAOQIXIEFENLEI:

DISANLEI,QIANRUSHENTI;YONGYISHIYONG、BAOCHIXINGMING;DUISHENTIJUBEIQIANZAIXINGFENGXIAN,DUIQIANQUANXISHU、SHIXIAOXINGWUBIYANKONGDEYILIAOJIXIE。

BIRU:6846QIANRUYUANCAILIAOHERENGONGFUWURENTIQIGUAN6821YILIAOQICAIYIBIAOYIQIJIQISHEBEI6870SHOUJIRUANJIANQUEZHENTUPIANCHULIRUANJIANQUEZHENSHUJUCHULIRUANJIAN6840YIXUEJIANYANFENXIYIZHICHENGJIAGUBANZHIKANGDING6854ZHENSHI、6822YILIAOQICAIDIANZIGUANGXUEQICAI、JIZHENSHI、ZHENLIAOSHIJIQISHEBEIJIQICAI、RUANGUAN、SHABU

SI、XUCHUSHIYUANCAILIAOMINGXI:

1.QIYEYINGYEZHIZHAOYINGYINJIAN

2.YEWUFANWEI

北京28登录3.FADINGDAIBIAOREN、ZHUYAOFUZEREN、PINZHIZERENREN、PINZHIGUANLIYUANSHENFENZHENGJIAN、XUELIZHENG(YINGYINJIAN)

北京28登录4.BANGONGSHISHEBEIWENJIANMULUMINGXI