皇冠篮球比分网

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有一个医疗器械项目想和我们谈谈吗?您可以填写右边的表格,让我们了解您的项目需求,这是一个良好的开始,我们将会尽快与你取得联系。当然也欢迎您给我们写信或是打电话,让我们听到你的声音!

格慧泰福(GHTF)皇冠篮球比分网 | 高端医疗器械临床注册专家

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上海市第二类医疗器械注册办事指南
 

    一、适用范围

    皇冠篮球比分网BENZHINANSHIYONGYUBENSHIDIERLEIYILIAOQIXIEZHUCEDESHENQINGYUBANLI。

    二、事项名称

    皇冠篮球比分网SHANGHAISHIDIERLEIYILIAOQIXIEZHUCESHENQING

    三、办理依据

    1、  GUOWUYUANLINGDI650HAO

    皇冠篮球比分网2、  GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI4HAO

    3、  GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI5HAO

    4、  GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI6HAO

    5、  GUANYUGUANCHESHISHI《YILIAOQIXIEJIANDUGUANLITIAOLI》YOUGUANSHIXIANGDEGONGGAO()

    6、  GUANYUGONGBUYILIAOQIXIEZHUCESHENBAOZILIAOYAOQIUHEPIZHUNZHENGMINGWENJIANGESHIDEGONGGAO()

    皇冠篮球比分网7、  GUANYUGONGBUTIWAIZHENDUANSHIJIZHUCESHENBAOZILIAOYAOQIUHEPIZHUNZHENGMINGWENJIANGESHIDEGONGGAO()

    皇冠篮球比分网8、  GUANYUFABUYILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZEDETONGGAO()

    9、  GUANYUFABUMIANYUJINXINGLINCHUANGSHIYANDEDIERLEIYILIAOQIXIEMULUDETONGGAO()

    10、 GUANYUFABUMIANYUJINXINGLINCHUANGSHIYANDEDISANLEIYILIAOQIXIEMULUDETONGGAO()

    11、 GUANYUFABUXUJINXINGLINCHUANGSHIYANSHENPIDEDISANLEIYILIAOQIXIEMULUDETONGGAO()

    12、 GUANYUFABUTIWAIZHENDUANSHIJILINCHUANGSHIYANJISHUZHIDAOYUANZEDETONGGAO()

    13、 GUANYUFABUTIWAIZHENDUANSHIJISHUOMINGSHUBIANXIEZHIDAOYUANZEDETONGGAO()

    14、 GUANYUSHISHI《YILIAOQIXIEZHUCEGUANLIBANFA》HE《TIWAIZHENDUANSHIJIZHUCEGUANLIBANFA》YOUGUANSHIXIANGDETONGZHI()

    15、 GUANYUYINFAYILIAOQIXIEJIANYANJIGOUKAIZHANYILIAOQIXIECHANPINJISHUYAOQIUYUPINGJIAGONGZUOGUIDINGDETONGZHI(SHIYAOJIANXIEGUAN)

    皇冠篮球比分网16、 GUANYUYINFAJINGNEIDISANLEIHEJINKOUYILIAOQIXIEZHUCESHENPICAOZUOGUIFANDETONGZHI()

    17、 GUANYUYINFAJINGNEIDIERLEIYILIAOQIXIEZHUCESHENPICAOZUOGUIFANDETONGZHI()

    四、办理机构

    SHANGHAISHISHIPINYAOPINJIANDUGUANLIJU(SHANGHAISHIHENANNANLU288HAO)

    五、审批条件

    皇冠篮球比分网1、  SHENQINGZHUCEDECHANPINYIJINGLIERUHUOZHEFUHEYILIAOQIXIEDINGYIJI)。

    皇冠篮球比分网2、  ZHUCESHENQINGRENCHIYOUQIYEYINGYEZHIZHAOHEZUZHIJIGOUDAIMAZHENG。

    皇冠篮球比分网3、  BANLIYILIAOQIXIEZHUCESHENQINGSHIWUDERENYUANYINGDANGSHOUZHUCESHENQINGRENWEITUO,BINGJUYOUXIANGYINGDEZHUANYEZHISHI,SHUXIYILIAOQIXIEZHUCEGUANLIDEFALV、FAGUI、GUIZHANGHEJISHUYAOQIU。

    皇冠篮球比分网4、  SHENBAOZILIAOQIQUAN,FUHE“SHANGHAISHIDIERLEIYILIAOQIXIEZHUCESHENBAOZILIAOYAOQIU”(QINGZHI“BIAOGEXIAZAI”YEMIANZHONGXIAZAICHAKANFUJIAN1)JIXIANGGUANFALVFAGUIDEGUIDINGTIAOJIAN。

    皇冠篮球比分网5、  SHANGHAISHISHIPINYAOPINJIANDUGUANLIJUGENJUYILIAOQIXIEZHUCESHENQINGRENDESHENQING,YIZHAOFADINGCHENGXU,DUIQINISHANGSHIYILIAOQIXIEDEANQUANXING、YOUXIAOXINGYANJIUJIQIJIEGUOJINXINGXITONGPINGJIA,YIJUEDINGSHIFOUTONGYIQIZHUCESHENQING。DUIZHUNYUZHUCEDEYILIAOQIXIE,BANFA《ZHONGHUARENMINGONGHEGUOYILIAOQIXIEZHUCEZHENG》。

    六、申请材料

    1、  SHENQINGBIAO(,XUANZE“DIERLEIYILIAOQIXIEZHUCE”JINXINGTIANBAOHEDAYIN);

    2、  ZHENGMINGXINGWENJIAN;

    3、  YILIAOQIXIEANQUANYOUXIAOJIBENYAOQIUQINGDAN;

    4、  ZONGSHUZILIAOZHIZHIJIWordWENDANG;

    5、  YANJIUZILIAOZHIZHIJIWordWENDANG;

    6、  SHENGCHANZHIZAOXINXI;

    皇冠篮球比分网7、  LINCHUANGPINGJIAZILIAO;

    8、  CHANPINFENGXIANFENXIZILIAO;

    9、  CHANPINJISHUYAOQIUZHIZHIWENDANGYISHILIANGFENJIWordWENDANG;

    10、 CHANPINZHUCEJIANYANBAOGAO;

    11、 CHANPINSHUOMINGSHUZHIZHIWENDANGYISHILIANGFENJIWordWENDANG;

    皇冠篮球比分网12、 ZUIXIAOXIAOSHOUDANYUANDEBIAOQIANYANGGAO;

    13、 FUHEXINGSHENGMINGJIZIWOBAOZHENGSHENGMING;

    14、 QIYERENWEIXUYAOSHENBAODEQITAWENJIANZILIAO。

    皇冠篮球比分网 WEIZHUMINGZILIAOWENDANGLEIXINGDE,TONGYIWEIZHIZHIWENDANG。

    皇冠篮球比分网WordWENDANGQINGSHANGCHUANZHIXINGZHENGXUKESHENQINGXINXIPINGTAI。

      LIERU“MIANYUJINXINGLINCHUANGSHIYANYILIAOQIXIEMULU”DECHANPIN,7.LINCHUANGPINGJIAZILIAOKEBUBAOKUOLINCHUANGSHIYANZILIAO。

    皇冠篮球比分网  WEILIERU“MIANYUJINXINGLINCHUANGSHIYANYILIAOQIXIEMULU”DECHANPIN,XUYAOJINXINGLINCHUANGSHIYAN,7.LINCHUANGPINGJIAZILIAOHAIYINGBAOKUOLINCHUANGSHIYANZILIAO。

    皇冠篮球比分网 WEILIERU“MIANYUJINXINGLINCHUANGSHIYANYILIAOQIXIEMULU”DECHANPIN,HAIKEYITONGGUODUITONGPINZHONGYILIAOQIXIELINCHUANGSHIYANHUOZHELINCHUANGSHIYONGHUODEDESHUJUJINXINGFENXIPINGJIA,NENGGOUZHENGMINGGAIYILIAOQIXIEANQUAN、YOUXIAODE,ZHUCESHENQINGRENKEZAISHENBAOZHUCESHIYUYISHUOMING,BINGTIJIAOXIANGGUANZHENGMINGZILIAO。

      上述资料的具体准备要求、部分资料附有的相关承诺和声明内容等要求,详见“上海市第二类医疗器械注册申报资料要求”(请至“表格下载”页面中下载查看附件1)。

    皇冠篮球比分网  SUOYOUSHENBAOZILIAOYINGJIAGAIGONGZHANG(JIQIFENGZHANG),RUYOUFUYINJIAN,XUZAIFUYINZILIAOSHANGJIAGAI“NEIRONGYUYUANJIANYIZHI”DEZHANG。(HUOKESHOUXIEBINGQIANZIQUEREN)

      递交资料按上述次序装订成册;每项资料之间有隔页纸;有资料目录,包括1、2级标题,以表格形式说明每项的卷和页码。资料装订、制定资料目录的要求,详见“上海市第二类医疗器械注册申报资料要求”(请至“表格下载”页面中下载查看附件1)。

    皇冠篮球比分网  “BIAOGEXIAZAI”YEMIANZHONGDEFUJIAN2WEISHENBAOZILIAOSHOULIYAOQIU。

    七、审批期限

    1、 SHOULI(ZILIAOXINGSHISHENCHA)5GEGONGZUORI

    2、 JISHUSHENPING60GEGONGZUORI(LINGYOU30GEGONGZUORIWANCHENGYUCHANPINYANZHI、SHENGCHANYOUGUANDEZHILIANGGUANLITIXIHECHA)

    3、 XINGZHENGSHENPI20GEGONGZUORI

    4、 HEFAPIJIAN10GEGONGZUORI

    八、审批证件

    皇冠篮球比分网《ZHONGHUARENMINGONGHEGUOYILIAOQIXIEZHUCEZHENG》,YOUXIAOQIWUNIAN。

    九、申请接收

    CHUANGKOUJIESHOU

    皇冠篮球比分网1、 SHANGHAISHISHIPINYAOPINJIANDUGUANLIJUYEWUSHOULIZHONGXIN

    JIESHOUDIZHI:SHANGHAISHIHENANNANLU288HAO

    JIESHOUSHIJIAN:ZHOUYI~ZHOUSI:9:00~11:30;13:30~17:00

                  ZHOUWU:9:00~11:30

    皇冠篮球比分网LIANXIDIANHUA:021-63356600ZHUAN6001/6003

    2、 SHANGHAISHISHIPINYAOPINJIANDUGUANLIJURENZHENGSHENPINGZHONGXINZIMAOQUFENZHONGXIN

    皇冠篮球比分网JIESHOUDIZHI:SHANGHAISHIJILONGLU9HAOZIMAOQUGUANWEIHUIZONGHEFUWUDATING

    JIESHOUSHIJIAN:ZHOUYI~ZHOUWU:9:00~11:30;13:30~16:30

    皇冠篮球比分网LIANXIDIANHUA:021-58696095/58696096

    十、咨询途径

    CHUANGKOUZIXUN

    1、 SHANGHAISHISHIPINYAOPINJIANDUGUANLIJUYEWUSHOULIZHONGXIN

    DIZHI:SHANGHAISHIHENANNANLU288HAO

    DIANHUA:021-63356600ZHUAN6001/6003

    2、 SHANGHAISHISHIPINYAOPINJIANDUGUANLIJURENZHENGSHENPINGZHONGXINZIMAOQUFENZHONGXIN

    DIZHI:SHANGHAISHIJILONGLU9HAOZIMAOQUGUANWEIHUIZONGHEFUWUDATING

    皇冠篮球比分网DIANHUA:021-58696095/58696096

    十一、投诉渠道

    ZIXUNBUMEN:TOUSUJUBAOSHOULIZHONGXIN

    DIANHUA:12331/962727

    十二、决定公开

    皇冠篮球比分网YILIAOQIXIEZHUCEZHENGXINXIZAISHANGHAISHISHIPINYAOPINJIANDUGUANLIJUZHENGWUWANGZHAN()DEGONGZHONGFUWULANMUGONGSHI。

一、CFDA注册检测咨询服务

 

1、确定注册产品分类及注册产品技术要求编写

2、确定符合承检能力的医疗器械检测所

3、准备、审核、编辑及整理检测所需申请文件

4、报呈注册检测申报文件

5、产品测试的过程跟进与协调

5、产品整改的协助与技术处理

二、CFDA产品临床试验CRO服务

1、Ⅱ类、Ⅲ类医疗器械临床试验豁免评价服务

2、Ⅱ类、Ⅲ类医疗器械及体外诊断试剂(IVD)临床试验服务

3、医疗器械临床前研究、动物试验

4、临床基地选择、临床方案设计、数据管理

5、临床试验生物统计、临床试验报告编写

6、临床试验监查、临床试验GCP规范指导

三、CFDA注册质量体系咨询服务

1、产品的范围和分类以及适应的报批程序, 报批的时间;

2、为您提供相关的国家和国际标准;

3、医疗器械设计研发及其生产和经营管理。

4、产品注册涉及的(GMP)质量体系咨询服务。

四、CFDA产品注册申报服务 (SDA Registration)

1、确定注册产品分类及相应报批程序

2、指导填写CFDA注册申报表格

3、准备、审核、编辑及整理注册申请文件

4、报呈申报文件

5、技术审评的内部沟通与跟进联系

6、协助产品注册的专家评审

7、跟踪注册进程及协助技术答辩

8、翻译有关申报资料

9、其他技术审评的资料补充协助

 

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