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二类医疗器械包括哪些?二类医疗器械如何备案

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二类医疗器械包括哪些?二类医疗器械如何备案

发布日期:2021-04-07 作者:贵阳二类医疗器械经营性备案 点击:

    医疗器械许可证全称医疗器械经营许可证,医疗器械经营许可证是医疗器械经营企业必须具备的证件,贵州办理医疗器械备案的企业,应当向省、自治区、直辖市人民政府药品监督管理部门备案;开办第三类医疗器械经营企业,应当经省、自治区、直辖市人民政府药品监督管理部门审查批准,并发给《医疗器械经营企业许可证》。医疗器械经营许可证现为后置审批,工商行政管理部门发给营业执照后申请审批。《医疗器械经营企业许可证》有效期为5年。


贵阳二类医疗器械经营性备案


    贵州办理医疗器械备案


    ERLEIYILIAOQIXIECHANPIN:


    PUTONGZHENCHAQIXIELEI:TIWENJI、XUEYAJI;


    WULIZHILIAOJIKANGFUSHEBEILEI:CILIAOQIJU;


    LINCHUANGJIANYANFENXIYIQILEI:JIATINGYONGXUETANGFENXIYIJISHIZHI;


    SHOUSHUSHI、JIJIUSHI、ZHENLIAOSHISHEBEIJIQIJULEI:YIYONGXIAOXINGZHIYANGJI SHOUTISHIYANGQIFASHENGQI;


    YIYONGWEISHENGCAILIAOJIFULIAOLEI:KUANGYONGTUOZHIMIAN、YIYONGTUOZHISHABU;


    YIYONGGAOFENZICAILIAOJIZHIPINLEI:BIYUNTAO、BIYUNMAODENG。


    还有市面经常看到的轮椅拐杖助行器等。


    DIERLEI、DISANLEIYILIAOQIXIESHENGCHANQIYE


    (YI)QIYEDESHENGCHAN、ZHILIANGHEJISHUFUZERENYINGDANGJUYOUYUSUOSHENGCHANYILIAOQIXIEXIANGSHIYINGDEZHUANYENENGLI,BINGZHANGWOXIANGGUANBUMENYOUGUANYILIAOQIXIEJIANDUGUANLIDEFALV、FAGUIHEGUIZHANGYIJIXIANGGUANCHANPINZHILIANG、JISHUDEGUIDING。ZHILIANGFUZERENBUDETONGSHIJIANRENSHENGCHANFUZEREN;


    (ER)QIYENEICHUJIYISHANGZHICHENGHUOZHEZHONGZHUANYISHANGXUELIDEJISHURENYUANZHANZHIGONGZONGSHUDEBILIYINGDANGYUSUOSHENGCHANCHANPINDEYAOQIUXIANGSHIYING;


    (SAN)QIYEYINGDANGJUYOUYUSUOSHENGCHANCHANPINJISHENGCHANGUIMOXIANGSHIYINGDESHENGCHANSHEBEI,SHENGCHAN、CANGCHUCHANGDIHEHUANJING。QIYESHENGCHANDUIHUANJINGHESHEBEIDENGYOUTESHUYAOQIUDEYILIAOQIXIEDE,YINGDANGFUHEGUOJIABIAOZHUN、XINGYEBIAOZHUNHEGUOJIAYOUGUANGUIDING;


    (四)企业应当设立质量检验机构,并具备与所生产品种和生产规模相适应的质量检验能力


    (WU)QIYEYINGDANGBAOCUNYUYILIAOQIXIESHENGCHANHEJINGYINGYOUGUANDEFALV、FAGUI、GUIZHANGHEYOUGUANJISHUBIAOZHUN。KAIBANDISANLEIYILIAOQIXIESHENGCHANQIYE,CHUYINGDANGFUHEYISHANGYAOQIUWAI,HAIYINGDANGTONGSHIJUBEIYIXIATIAOJIAN:


    1)FUHEZHILIANGGUANLITIXIYAOQIUDENEISHENYUANBUSHAOYULIANGMING;


    2)XIANGGUANZHUANYEZHONGJIYISHANGZHICHENGHUOZHEDAZHUANYISHANGXUELIDEZHUANZHIJISHURENYUANBUSHAOYULIANGMING。


     《YILIAOQIXIEJIANDUGUANLITIAOLI》DISANSHITIAOGUIDING:“CONGSHIDIERLEIYILIAOQIXIEJINGYINGDE,YOUJINGYINGQIYEXIANGSUOZAIDISHEQUDESHIJIRENMINZHENGFUSHIPINYAOPINJIANDUGUANLIBUMENBEIANBINGTIJIAOQIFUHEBENTIAOLIDIERSHIJIUTIAOGUIDINGTIAOJIANDEZHENGMINGZILIAO”。


    贵州办理医疗器械备案条件


    1、SHENQINGDUIXIANGYINGWEIQIYE;


    2、JUYOUYUJINGYINGGUIMOHEJINGYINGFANWEIXIANGSHIYINGDEZHILIANGGUANLIJIGOUHUOZHEZHILIANGGUANLIRENYUAN,ZHILIANGGUANLIRENYUANYINGDANGJUYOUGUOJIARENKEDEXIANGGUANZHUANYEXUELIHUOZHEZHICHENG;


    3、JUYOUYUJINGYINGGUIMOHEJINGYINGFANWEIXIANGSHIYINGDEDEJINGYING、ZHUCUNCHANGSUO,ZHUCUNTIAOJIAN;JINGYINGCHANGSUOHEKUFANGBUDESHEZAIJUMINZHUZHAINEI、JUNSHIGUANLIQU(BUHANKEZULINQU)YIJIQITABUSHIHEJINGYINGDECHANGSUO;QUANBUWEITUOQITAYILIAOQIXIEJINGYINGQIYEZHUCUNDEKEYIBUSHELIKUFANG;


    4、JUYOUYUJINGYINGDEYILIAOQIXIEXIANGSHIYINGDEZHILIANGGUANLIZHIDU;


    5、具备与经营的医疗器械产品相适应的专业指导、技术培训和售后服务的能力,或者约定由第三方提供技术支持。


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相关标签:贵阳二类医疗器械经营性备案,贵州办理医疗器械备案,贵州办理医疗器械经营性备案

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