广东11选5

广东11选5

ZAIXIANKEFU

办理医疗器械经营备案或经营许可证要具备什么条件

  经营第二类、第三类疗器械应当持有《医疗器械经营企业许可证》。为避免疗器械经营领域过于杂乱泛滥、减少百姓健康风险、规范医疗器械市场,国家逐步提高行业门槛,包括人员、场地、设施及经营软件等方面的要求。

 

广东11选5  YILIAOQIXIEKEYIFENWEIYILEI、ERLEI、SANLEI;YILEIYILIAOQIXIEGONGSIBUXUYAOSHENQINGXUKEZHENG,HEYIBANGONGSIZHUCEWUYI;ZHINENGJINGYINGPUTONGDEYILIAOQIXIESHEBEI。ERLEIYILIAOQIXIEGONGSIXUBANLIYILIAOQIXIEJINGYINGBEIAN、SANLEIYILIAOQIXIEGONGSIXUBANLIYILIAOQIXIEJINGYINGXUKEZHENG,ERLEIYILIAOQIXIEJINGYINGBEIANBUYUNXUCONGSHISANLEIYILIAOQIXIEXIAOSHOUYEWU;SANLEIYILIAOQIXIEGONGSIBUKECONGSHIERLEIYILIAOQIXIEXIAOSHOUYEWU,ER、SANLEIYILIAOQIXIEJINGYINGKEJIANYINGDANJUNXUJINXINGLINGWAISHENBAN。

 

 

  GUOJIAFALVFAGUIGUIDING:《YILIAOQIXIEJINGYINGXUKEZHENG》YOUXIAOQIWEI5NIAN,YOUXIAOQIJIEMANXUYAOYANXUDE,YILIAOQIXIEJINGYINGQIYEYINGDANGZAIYOUXIAOQIJIEMAN6GEYUEQIAN,XIANGYUANFAZHENGBUMENTICHU《YILIAOQIXIEJINGYINGXUKEZHENG》YANXUSHENQING。

 

  YUANFAZHENGBUMENYINGDANGANZHAOFALVFAGUIDEGUIDINGDUIYANXUSHENQINGJINXINGSHENHE,BIYAOSHIKAIZHANXIANCHANGHECHA,ZAI《YILIAOQIXIEJINGYINGXUKEZHENG》YOUXIAOQIJIEMANQIANZUOCHUSHIFOUZHUNYUYANXUDEJUEDING。FUHEGUIDINGTIAOJIANDE,ZHUNYUYANXU,YANXUHOUDE《YILIAOQIXIEJINGYINGXUKEZHENG》BIANHAOBUBIAN。BUFUHEGUIDINGTIAOJIANDE,ZELINGXIANQIZHENGGAI;ZHENGGAIHOURENGBUFUHEGUIDINGTIAOJIANDE,BUYUYANXU。YUQIWEIZUOCHUJUEDINGDE,SHIWEIZHUNYUYANXU。

 

  办理医疗器械经营备案或经营许可证必须具备以下条件:

 

  1.JUYOUYUJINGYINGFANWEIHEJINGYINGGUIMOXIANGSHIYINGDEZHILIANGGUANLIJIGOUHUOZHEZHILIANGGUANLIRENYUAN,ZHILIANGGUANLIRENYUANYINGDANGJUYOUGUOJIARENKEDEXIANGGUANZHUANYEXUELIHUOZHEZHICHENG;(YAOQIU:BIXUWEIYILIAOQIXIEZHUANYEDAZHUANYISHANGXUELI3NIANYISHANGJINGYAN,2RENYISHANG);

 

  2.JUYOUYUJINGYINGFANWEIHEJINGYINGGUIMOXIANGSHIYINGDEJINGYING、ZHUCUNCHANGSUO;(YAOQIU:JINGYINGCHANGDIMIANJIXUYUJINGYINGCHANPINHEJINGYINGFANGSHIJIFALVFAGUIXIANGFUHE);

 

广东11选5  3.JUYOUYUJINGYINGFANWEIHEJINGYINGGUIMOXIANGSHIYINGDEZHUCUNTIAOJIAN,QUANBUWEITUOQITAYILIAOQIXIEJINGYINGQIYEZHUCUNDEKEYIBUSHELIKUFANG;(YAOQIU:JINGYINGSHESHISHEBEIXUYUJINGYINGCHANPINJIJINGYINGFANGSHIJIFALVFAGUIXIANGFUHE);

 

广东11选5  4.JUYOUYUJINGYINGDEYILIAOQIXIEXIANGSHIYINGDEZHILIANGGUANLIZHIDU;(YAOQIU:JINGYINGGUANLIZHIDUXUYUJINGYINGFANGSHIJIJINGYINGCHANPINHEFALVFAGUIXIANGFUHE);

 

广东11选5  5.JUBEIYUJINGYINGDEYILIAOQIXIEXIANGSHIYINGDEZHUANYEZHIDAO、JISHUPEIXUNHESHOUHOUFUWUDENENGLI。