皇冠篮球比分网

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格慧泰福(GHTF)皇冠篮球比分网 | 高端医疗器械临床注册专家

皇冠篮球比分网24XIAOSHIMIANFEIZIXUNREXIAN:

皇冠篮球比分网400-9905-168

TIANXIENINDEXIANGMUXINXI

TIANXIEWANBIAODANHOU,QINGDIANJIYIXIARENYIYIZHONGGOUTONGFANGSHI:

皇冠篮球比分网

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深圳第一类医疗器械备案办理

深圳市《第一类医疗器械备案》最新办事指南

注意事项:在递交书面申报材料前,应通过深圳市药品监督管理局协同监管电子平台(http://203.91.57.46:9080/szyj/)网上提交行政许可申请。企业在提交纸质申请材料时须同时提交该预受理号。

备案时应一并提交含有“第一类医疗器械备案表”内容(含附件)的电子文档(Excel形式)

SHENBAOCAILIAO

SHENBAOCAILIAOYAOQIU

BEIZHU

1.DIYILEIYILIAOQIXIEBEIANBIAO

皇冠篮球比分网BEIANBIAOZHONG“CHANPINMINGCHENG(TIWAIZHENDUANSHIJIWEICHANPINFENLEIMINGCHENG,YIXIATONG)”、“CHANPINMIAOSHU”HE“YUQIYONGTU”YINGYUDIYILEIYILIAOQIXIECHANPINMULUHEXIANGYINGTIWAIZHENDUANSHIJIFENLEIZIMULUXIANGYINGNEIRONGYIZHI。QIZHONG,CHANPINMINGCHENGYINGDANGYUMULUSUOLIENEIRONGXIANGTONG;CHANPINMIAOSHU、YUQIYONGTU,YINGDANGYUMULUSUOLIENEIRONGXIANGTONGHUOZHESHAOYUMULUNEIRONG。(BEIANRENMINGCHENG、ZHUCEDIZHIYINGYUQIYEYINGYEZHIZHAOXINXIYIZHI)

皇冠篮球比分网TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG,BINGZAIDIANZIPINGTAIZHONGSAOMIAOSHANGCHUAN。

2.ANQUANFENGXIANFENXIBAOGAO

1.YINGANZHAOYY 0316《YILIAOQIXIEFENGXIANGUANLIDUIYILIAOQIXIEDEYINGYONG》DEYOUGUANYAOQIUBIANZHI,ZHUYAOBAOKUOYILIAOQIXIEYUQIYONGTUHEYUANQUANXINGYOUGUANTEZHENGDEPANDING、WEIHAIDEPANDING、GUJIMEIGEWEIHAICHUJINGDEFENGXIAN;DUIMEIGEYIPANDINGDEWEIHAICHUJING,PINGJIAHEJUEDINGSHIFOUXUYAOJIANGDIFENGXIAN;FENGXIANKONGZHICUOSHIDESHISHIHEYANZHENGJIEGUO,BIYAOSHIYINGYINYONGJIANCEHEPINGJIAXINGBAOGAO;RENHEYIGEHUODUOGESHENGYUFENGXIANDEKEJIESHOUXINGPINGDINGDENG,XINGCHENGFENGXIANGUANLIBAOGAO。

2.TIWAIZHENDUANSHIJIYINGDUICHANPINSHOUMINGZHOUQIDEGEGEHUANJIE,CONGYUQIYONGTU、KENENGDESHIYONGCUOWU、YUANQUANXINGYOUGUANDETEZHENG、YIZHIHEKEYUJIANDEWEIHAIDENGFANGMIANDEPANDINGJIDUIHUANZHEFENGXIANDEGUJIJINXINGFENGXIANFENXI、FENGXIANPINGJIAJIXIANGYINGDEFENGXIANKONGZHIDEJICHUSHANG,XINGCHENGFENGXIANGUANLIBAOGAO。

TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

3.CHANPINJISHUYAOQIU

YINGANZHAO《YILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZE》BIANZHI。

皇冠篮球比分网TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

4.CHANPINJIANYANBAOGAO

YINGWEICHANPINDEQUANXINGNENGZIJIANBAOGAOHUOWEITUOJIANYANBAOGAO,JIANYANDECHANPINYINGDANGJUYOUDIANXINGXING。

TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

5.LINCHUANGPINGJIAZILIAO

1.XIANGSHUCHANPINYUQIYONGTU,BAOKUOCHANPINSUOTIGONGDEGONGNENG,BINGKEMIAOSHUQISHIYONGDEYILIAOJIEDUAN(RUZHILIAOHOUDEJIANCE、KANGFUDENG),MUBIAOYONGHUJIQICAOZUOGAICHANPINYINGJUBEIDEJINENG/ZHISHI/PEIXUN;YUQIYUQIZUHESHIYONGDEQIXIE。

皇冠篮球比分网2.XIANGSHUCHANPINYUQISHIYONGHUANJING,BAOKUOGAICHANPINYUQISHIYONGDEDIDIANRUYIYUAN、YILIAO/LINCHUANGSHIYANSHI、JIUHUCHE、JIATINGDENG,YIJIKENENGHUIYINGXIANGQIANQUANXINGHEYOUXIAOXINGDEHUANJINGTIAOJIAN(RUWENDU、SHIDU、GONGLV、YALI、YIDONGDENG)。

皇冠篮球比分网3.XIANGSHUCHANPINSHIYONGRENQUN,BAOKUOMUBIAOHUANZHERENQUNDEXINXI(RUCHENGREN、ERTONGHUOXINSHENGER),HUANZHEXUANZEBIAOZHUNDEXINXI,YIJISHIYONGGUOCHENGZHONGXUYAOJIANCEDECANSHU、KAOLVDEYINSU。

4.XIANGSHUCHANPINJINJIZHENG,RUSHIYONG,YINGMINGQUESHUOMINGGAIQIXIEJINZHISHIYONGDEJIBINGHUOQINGKUANG。

5.YISHANGSHITONGLEICHANPINLINCHUANGSHIYONGQINGKUANGDEBIDUISHUOMING。

6.TONGLEICHANPINBULIANGSHIJIANQINGKUANGSHUOMING。

TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

6.CHANPINSHUOMINGSHUJIZUIXIAOXIAOSHOUDANYUANBIAOQIANSHEJIYANGGAO

1.YINGFUHE《YILIAOQIXIESHUOMINGSHU、BIAOQIANHEBAOZHUANGBIAOSHIGUANLIGUIDING》DENGXIANGYINGFAGUIGUIDING。

皇冠篮球比分网2.TIWAIZHENDUANSHIJICHANPINYINGANZHAO《TIWAIZHENDUANSHIJISHUOMINGSHUBIANXIEZHIDAOYUANZE》DEYOUGUANYAOQIU,BINGCANKAOYOUGUANJISHUZHIDAOYUANZEBIANXIECHANPINSHUOMINGSHU。

TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

7.SHENGCHANZHIZAOXINXI

1.DUISHENGCHANGUOCHENGXIANGGUANQINGKUANGDEGAISHU。WUYUANYILIAOQIXIEYINGMINGQUECHANPINSHENGCHANJIAGONGGONGYI,ZHUMINGGUANJIANGONGYIHETESHUGONGYI。YOUYUANYILIAOQIXIEYINGTIGONGCHANPINSHENGCHANGONGYIGUOCHENGDEMIAOSHUXINGZILIAO,KECAIYONGLIUCHENGTUDEXINGSHI,SHISHENGCHANGUOCHENGDEGAISHU。TIWAIZHENDUANSHIJIYINGGAISHUZHUYAOSHENGCHANGONGYI,BAOKUO:GUXIANGZAITI、XIANSEXITONGDENGDEMIAOSHUJIQUEDINGYIJU,FANYINGTIXIBAOKUOYANGBENCAIJIJICHULI、YANGBENYAOQIU、YANGBENYONGLIANG、SHIJIYONGLIANG、FANYINGTIAOJIAN、XIAOZHUNFANGFA(RUGUOXUYAO)、ZHIKONGFANGFADENG。

皇冠篮球比分网2.YINGGAISHUYANZHI、SHENGCHANCHANGDIDESHIJIQINGKUANG。

TIJIAOYUANJIANYIFEN,JIAGAIQIYEGONGZHANG。

8.ZHENGMINGXINGWENJIAN

皇冠篮球比分网QIYEYINGYEZHIZHAO、ZUZHIJIGOUDAIMAZHENGXIANGGUANXINXI(JUNYINGZAIYOUXIAOQINEI)。

皇冠篮球比分网YOUSHENCHAJIGUANWANGSHANGCHAXUNDAYIN。

9.FUHEXINGSHENGMING

皇冠篮球比分网1.SHENGMINGFUHEYILIAOQIXIEBEIANXIANGGUANYAOQIU;

2.声明本产品符合第一类医疗器械产品目录或相应体外诊断试剂分类子目录的

 

深圳市药品监管局关于第一类医疗器械产品备案、生产备案、第二类医疗器械经营备案的通知

GEYOUGUANDANWEI:

皇冠篮球比分网  GENJU2014NIAN6YUE1RIQISHISHIDEXINXIUDING《YILIAOQIXIEJIANDUGUANLITIAOLI》JINGSHENHEGUOJIASHIPINYAOPINJIANDUGUANLIZONGJU2014NIANDI8HAOTONGGAO、2014NIANDI25、26HAOGONGGAODEYAOQIU,ZI2014NIAN6YUE1RIQI,DIYILEIYILIAOQIXIESHIXINGCHANPINBEIANGUANLI,DIYILEIYILIAOQIXIESHENGCHANHEDIERLEIYILIAOQIXIEJINGYINGYEGAIWEIBEIAN。GEQIYEBANLIXIANGGUANBEIANDEDIDIANRUXIA:

  DIYILEIYILIAOQIXIECHANPINBEIANHEDIYILEIYILIAOQIXIESHENGCHANBEIANDAOSHENZHENSHIYAOPINJIANDUGUANLIJUSHOULICHUANGKOU(SHENZHENSHIFUTIANQUFUZHONGSANLUSHIMINZHONGXINXINGZHENGFUWUDATING44、45CHUANGKOU)BANLI;DIERLEIYILIAOQIXIEJINGYINGBEIAN,FUTIAN、LUOHU、NANSHAN、YANTIANXIAQUQIYEDAOSHENZHENSHIYAOPINJIANDUGUANLIJUSHOULICHUANGKOUBANLI,BAOAN、GUANGMING、LONGHUAXIAQUQIYEDAOBAOANFENJUCHUANGKOUBANLI,LONGGANG、PINGSHAN、DAPENGXIAQUQIYEDAOLONGGANGFENJUCHUANGKOUBANLI。BANLIGUOCHENGZHONGXUYAOTIANXIEDEXIANGGUANBIAOGE、TIJIAODEZILIAOYAOQIUJILIUCHENGDENGQINGDAOSHENZHENSHIYAOPINJIANDUGUANLIJUWANGZHANBANSHIZHINANZHONGLIULANBINGXIAZAIXIANGGUANYAOQIU。

  TECITONGZHI。

皇冠篮球比分网  SHENZHENSHIYAOPINJIANDUGUANLIJU

  2014NIAN6YUE6RI

   GHTF格慧泰福医药技术服务机构可以提供:

1、一类医疗器械备案申报资料制作服务

2、一类医疗器械备案产品技术要求资料编写服务

3、一类医疗器械备案资料有关临床评价资料编写服务

4、一类医疗器械备案有关的其他申请事项咨询服务

5、一类医疗器械风险分析报告编写服务

6、一类医疗器械生产备案申请服务


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