皇冠篮球比分网

Hi,are you ready?
准备好开始了吗?
那就与我们取得联系吧
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) | 高端医疗器械临床注册专家

皇冠篮球比分网24XIAOSHIMIANFEIZIXUNREXIAN:

400-9905-168

TIANXIENINDEXIANGMUXINXI

TIANXIEWANBIAODANHOU,QINGDIANJIYIXIARENYIYIZHONGGOUTONGFANGSHI:

我们的服务
体外诊断医疗器材申请 CE 认证指南
 

TIWAIZHENDUANYILIAOQICAISHENQING CE RENZHENGZHINAN

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


MU

LU


YI.

ER.

QIANYAN......................................................................................................................... 3

TIWAIZHENDUANYILIAOQICAISHENQING CE RENZHENGDEBUZHOU.............................................................. 3


DIYIBU

DIERBU

DISANBU

DISIBU

QUEDINGCHANPINSHIFOUWEI IVD ................................................................................... 3

皇冠篮球比分网QUEDING IVD CHANPINDEFENLEIJIXUANZEFUHEXINGPINGJIATUJING........................................... 4

皇冠篮球比分网JIANLIHEWEIHUZHILIANGGUANLITIXI............................................................................ 6

皇冠篮球比分网ZHUNBEI CE JISHUWENJIAN......................................................................................... 7


CE JISHUWENJIANDEQINGDAN ........................................................................................................ 7

JIBENYAOQIUJIANCHABIAO ............................................................................................................. 8


DIWUBU

DILIUBU

DIQIBU

DIBABU

XUANZEHESHIDEGONGGAOJIGOU.................................................................................... 9

HUODE CE ZHENGSHUJIZHUCE..................................................................................... 9

List A CHANPINDEPIPIJIAN................................................................................... 10

皇冠篮球比分网SHICHANGHOUJIANDUHEJINGJIEXITONG.............................................................................. 10


Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


YI.

QIANYAN


皇冠篮球比分网OUZHOUWEIYUANHUIYU 1998 NIAN 10 YUE 27 RIZHENGSHITONGGUO 98/79/EC TIWAIZHENDUANYILIAOQICAIZHILING(In Vitro

Diagnostic Medical Devices Directive,YIXIAJIANCHENG IVDD ZHILING),BINGGONGGAOYU 1998 NIAN 12 YUE 7 RIDE

DI L331 HAOOUMENGGONGBAOSHANG。GENJUGONGBAODENEIRONG,OUMENGGECHENGYUANGUOBIXUYU 2000 NIAN 6 YUE 7 RIZHIQIANWANCHENGZHIXINGBENZHI

LINGSUOXUYAODEXIANGGUANFAGUIMINGLINGXIUZHIDINGYUGONGGAO,ZI 2003 NIAN 12 YUEQI,SUOYOUZAIOUMENGGECHENGYUANGUOXIAOSHOUDETIWAIZHENDUAN

YILIAOQICAI(In Vitro Diagnostic Medical Devices,YIXIAJIANCHENG IVD)JUNXUYIZHAOBENZHILINGWANCHENGFUHEXINGPING

JIACHENGXU,TIESHANG CE BIAOSHI,CAINENGZAIOUMENGSHANGSHI。

皇冠篮球比分网OUMENGZAOQIANYOU 15 GECHENGYUANGUO,2004 NIAN 5 YUE,OUGONGTIXINZENGLESHIGECHENGYUANGUO,ZHEI 10 GEXINCHENGYUANSHI:SAIPU

LUSI、JIEKE、AISHANIYA、XIONGYALI、LITAOWAN、LATUOWEIYA、MAERTA、BOLAN、SILUOFAKE、SILUOWENNIYA,

2007 NIANDE 1 YUE,BAOJIALIYAHELUOMALIYAYEJIARULEOUMENG,JIASHANGYUANYOUDE 15 GECHENGYUANGUO,AODILI、BILISHI、

皇冠篮球比分网DANMAI、FENLAN、FAGUO、DEGUO、XILA、AIERLAN、YIDALI、LUSENBAO、PUTAOYA、XIBANYA、RUIDIAN、HELAN、YING

GUO。OUMENGMUQIANYIYOU 27 GECHENGYUANGUO。RONGYIRANGRENHUNXIAODESHIOUGONGTIBINGMEIYOUXIAOSHI,YUANLAIOUGONGTIDE 3 GEGUOJIA,

皇冠篮球比分网NUOWEI,BINGDAOHELIESHIZHIDUNYESHICHENGREN IVDD ZHILINGDE。YINCI,IVDD ZHILINGSHIYONGDEGUOJIAXIANZAIYOU 30 GE。CHUCIZHI

皇冠篮球比分网WAI,HAIYOUYIXIEQIANOUGONGTIGUOJIADEZHIMINDI,YIJIZHENGZAISHENQINGJIARUOUMENGDEGUOJIA,RUTUERQI、KELUODIYA,YESHI

YONGZHEIGEZHILING。

YOUCIKEYIKANCHU,OUMENGYISHIYIGEYUELAIYUEDADEDANYISHICHANG,GUONEIDETIWAIZHENDUANYILIAODUANQICAISHENGCHANCHANGJIAYEYI

SHIDAOCIDIAN,DANZHEIGESHICHANGSHIYOUMENJIANDE,ZHEIGEMENJIANJIUSHI CE RENZHENG。GUONEIDESHENGCHANCHANGJIADUICIXIANGDUIMOSHENG,BEIGAN

皇冠篮球比分网KUNNAN,BENWENJIUCITIGONGYIXIECANKAO。


ER.

DIYIBU

TIWAIZHENDUANYILIAOQICAISHENQING CE RENZHENGDEBUZHOU

QUEDINGCHANPINSHIFOUWEI IVD


ZHIZAOSHANGSHOUXIANYAOGENJUTIWAIZHENDUANYILIAOQICAIDEDINGYI,QUEDINGGAICHANPINSHIFOUWEITIWAIZHENDUANYILIAOQICAI,GENJUOUMENG

皇冠篮球比分网TIWAIZHENDUANYILIAOQICAIZHILING 98/79/EC DEDINGYI, TIWAIZHENDUANYILIAOQICAIDEDINGYISHIZHIRENHESHIJI、XIAOZHENGWUZHI、DUI

ZHAOWUZHI、YIQI、ZHUANGZHI、SHEBEIHUOXITONGDEYILIAOQIXIE,WULUNSHIDANDUHUOHEBINGSHIYONG,YOUZHIZAOSHANGZHIDINGQIYONGTUWEIYONG

皇冠篮球比分网YUTIWAIJIANYANCAIZIRENTIDEYANGBENBAOKUOXUEYEYUZUZHI,DANDUHUOZHUYAOYONGYITIGONGYIXIAXIANGGUANXINXIZHE:

皇冠篮球比分网–GUANYUSHENGLIHUOBINGLIZHUANGTAI﹔

–HUOGUANYUXIANTIANYICHANG﹔

–HUOJUEDINGYUQIANZAIJIESHOUYIZHIRENYUANZHIANQUANXINGYUJIANRONGXING﹔

–HUOJIANKONGZHILIAOXIAOGUO。

YANGBENRONGQIYEBEIRENWEISHITIWAIZHENDUANYILIAOQICAI,WULUNSHIFOUWEIZHENKONGXINGSHI,YOUZHIZAOSHANGZHIDINGYONGYICHUCUNCAIQUZI

皇冠篮球比分网RENTIDEYANGBEN,GONGTIWAIZHENDUANJIANYANZHIYONGZHEJIESHUZHI。BIRUYICIXINGZHENKONGCAIXUEGUAN。YIBANSHIYANSHIQICAIBINGBUSHUYUTI

WAIZHENDUANYILIAOQICAIZHILIE,CHUFEIGENJUQICHANPINTEZHENG,ZHIZAOSHANGTEBIESHENGMINGGAIQICAISHITIWAIZHENDUANYILIAOQICAI。

皇冠篮球比分网ZHIZAOSHANGZHIYOUXIANQUEDINGLETADECHANPINSHI IVD,CAINENGJIXUXIAQU,FOUZEJIUYAOXUANZEQITADEXIANGDUIYINGDEFANGFA。MU

QIANGUONEIYOUDEZHIZAOSHANGZAIZHEIFANGMIANYUDAOLEMAFAN,BIRUYOUSHENGCHANLANYONGDUPINDEJIANCESHIJIHE,HUOZHESHIYUNDONGYUANXINGFENJI

皇冠篮球比分网JIANCESHIJIHE,ANZHAO IVDD ZHILINGDEDINGYI,ZHEIXIECHANPINBUSHUYUTIWAIZHENDUANYILIAOQICAI,YEJIUBUNENGAN IVDD ZHILINGLAI

SHENQING CE RENZHENG。

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


DIERBU

皇冠篮球比分网QUEDING IVD CHANPINDEFENLEIJIXUANZEFUHEXINGPINGJIATUJING


ZHIZAOSHANGZAIQUEDINGLETADECHANPINSHI IVD,NEIMEXIAYIBUJIUYAOQUEDINGTADEFENLEI。GENJU IVDD ZHILINGYAOQIU,IVD CHAN

PINKEFENCHENG 5 LEI,List A、List B、ZIWOJIANCEQICAI(XUETANGJIANCECHUWAI)、QITALEICHANPIN、XINGNENGPINGJIAQICAI,

MEIYILEIDEFUHEXINGPINGJIATUJING(YEJIUSHIHUODE CE RENZHENGDETUJING)GEBUXIANGTONG。

1. List A CHANPIN:

GENJU IVDD FULU II YAOQIU,YIXIACHANPINSHI List A CHANPIN:

皇冠篮球比分网a. JUEDINGXUEXING ABO、rhesus(C, c, E, e) 、anti-Kell DESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANZHIXIAOZHENG

WUZHIYUDUIZHAOWUZHI;

b. JIANCE、QUEREN、LIANGHUARENTIYANGBENYIBIAODING HIV GANRAN (HIV1, 2) 、HTLV I, II JI B, C, D XINGGAN

皇冠篮球比分网YANDESHIJIJISHIJICHANPIN,BAOKUOXIANGGUANZHIXIAOZHENGWUZHIYUDUIZHAOWUZHI。

皇冠篮球比分网List A CHANPINDEFENXIANZUIGAO,YINCIKONGZHIYEZUIYAN,XUYAOJINXINGPIPIJIAN。GENJU IVDD ZHILINGDIJIUZHANGDEGUIDING,

皇冠篮球比分网List A LEICHANPINDEFUHEXINGPINGJIATUJINGRUXIATU:


FULU V

EC XINGSHISHIYAN

FULU VII

ZHIZAOZHILIANGBAOZHENG

FULU IV

QUANZHILIANGBAOZHENGTIXI

GONGGAOJIGOUDUICHANPINSHEJIWENDANGDESHENHE


皇冠篮球比分网GONGGAOJIGOUANFULU VII.5 HUO IV.6 DUIYISHENGCHANDECHANPINYANZHENG(PIPIJIAN)

XXXX


2.

皇冠篮球比分网List B CHANPIN:


GENJU IVDD FULU II YAOQIU,YIXIACHANPINSHI List B CHANPIN:

a. JIANCEKANG D YUKANG K XUEXINGDESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI;

皇冠篮球比分网b. JIANCEYICHANGHONGXIBAOKANGTIDESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI;

c. JIANCEYULIANGHUARENTIYANGBENSHIFOUYOUYIXIADEXIANTIANGANRAN,RUFENGZHEN, GONGXINGCHONGDESHIJIHUOSHIJICHANPIN,BAOKUO

XIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI;

皇冠篮球比分网d. YONGYIZHENDUANSHIFOUYOUYICHUANJIBING,BENBINGTONGSUANNIAOZHENGDESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAO

WUZHI;

皇冠篮球比分网e. JIANCEJUXIBAOBINGDU、YIYUANTIGANRANDESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI;

f. JIANCE HLA XINGSHI DR, A, B DESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI;

g. JIANCEZHONGLIUBIAOJIWUQIANLIEXIANTEYIKANGYUAN(PSA )DESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAO

WUZHI;

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


皇冠篮球比分网h. TEDINGYONGYUPINGGU 21 SANTIZONGHEZHENGFENGXIANDESHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI、RUAN

JIAN;

皇冠篮球比分网i. XUETANGZIWOJIANCEDEZHENDUANSHIJIHUOSHIJICHANPIN,BAOKUOXIANGGUANXIAOZHENGWUZHIYUDUIZHAOWUZHI。

GENJU IVDD ZHILINGDIJIUZHANGDEGUIDING,List B LEICHANPINDEFUHEXINGPINGJIATUJINGRUXIATU:


皇冠篮球比分网FULU VII

ZHIZAOZHILIANGBAOZHENG

FULU V

EC XINGSHISHIYAN

FULU VI

EC YANZHENG

XXXX

FULU IV

QUANZHILIANGBAOZHENGTIXI


3.

皇冠篮球比分网ZIWOJIANCEQICAI(XUETANGJIANCECHUWAI)

皇冠篮球比分网GENJU IVDD ZHILINGDEDINGYI,ZIWOJIANCEQICAIZHIZHIZAOSHANGZHIDINGQIYONGTUWEIKEBEIGERENZAIJIAZHONGSHIYONGDEQICAI。

GENJU IVDD ZHILINGDIJIUZHANGDEGUIDING,ZIWOJIANCEQICAI(XUETANGJIANCECHUWAI)DEFUHEXINGPINGJIATUJINGRUXIATU:


皇冠篮球比分网FULU III

ZHIZAOSHANGZIWOSHENGMING

FULU V

EC XINGSHISHIYAN


GONGGAOJIGOUDUISHEJI

WENDANGSHENHE

FULU VII

ZHIZAOZHILIANGBAOZHENG

FULU VI

EC YANZHENG

FULU IV

QUANZHILIANGBAOZHENGTIXI


XXXX

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


4. QITALEICHANPIN

皇冠篮球比分网FANBUSHUYUSHANGSHUFENLEIDETIWAIZHENDUANYILIAOQICAI,KEYIFENDAOQITALEICHANPIN。

皇冠篮球比分网GENJU IVDD ZHILINGDIJIUZHANGDEGUIDING,GAILEICHANPINDEFUHEXINGPINGJIATUJINGRUXIATU:

FULU III

ZHIZAOSHANGZIWOSHENGMING


5.

XINGNENGPINGJIAQICAI (devices for performance evaluation)


ZHIZAIYIXUEFENXISHIYANSHIZHONGSHIYONG,YONGYIPINGGUQIXINGNENGDEQICAI。DUIYUZUOXINGNENGPINGJIADEQICAI,BUXUYAOZAICHANPIN

皇冠篮球比分网SHANGBIAOSHANG CE BIAOZHI,DANZHIZAOSHANGYAOANZHAO IVDD FULU VIII DEYAOQIUXIECHUSHENGMING,YIBEIZHUGUANDANGJUDEJIANCHA。


DISANBU

JIANLIHEWEIHUZHILIANGGUANLITIXI


皇冠篮球比分网ZHIZAOSHANGZAIQUEDINGLECHANPINDEFENLEIJIFUHEXINGPINGJIADETUJINGHOU,JIUYAOGENJU IVDD DEYAOQIU,JIANLIZHILIANGGUANLITI

皇冠篮球比分网XI,YIFUHE IVDD DEYAOQIU。MUQIANGUOLEIDETIWAIZHENDUANYILIAOQICAISHENGCHANCHANGJIA,YIBANDOUANZHAO SFDA DEYAOQIU,JIANLI

皇冠篮球比分网LE GMP DEZHILIANGGUANLITIXI,DAN GMP BIAOZHUNBUSHI IVDD DEXIEDIAOBIAOZHUN,IVDD DUIZHILIANGGUANLITIXIDEXIEDIAOBIAOZHUNSHI

ISO13485/8:1996 HUO ISO13485: 2003,YINCI,CHANGJIAYINGANZHAO ISO13485 DEYAOQIUJIANLIZHILIANGGUANLITIXI,ZAI

皇冠篮球比分网ZENGJIA IVDD DEYIXIETESHUYAOQIU,RUJINGJIEXITONG,ZIWOFUHEXINGSHENGMINGDENG。

皇冠篮球比分网DUIYUYIJINGJIANLILE GMP TIXIDECHANGJIALAISHUO,XUYAOJIANLIYIGE GMP/ISO13485/IVDD SANHEYIDETONGYIDEZHILIANG

皇冠篮球比分网GUANLITIXI,YIBEIBUTONGJIGOUSHENHEDEXUYAO。ZHILIANGGUANLITIXIWENJIANDEBIANXIESHIGENANDIAN,ZAICIZUOYIGEJIANSHU。

ZAIWEIDAPOYUANLAISUOSHUXIDE GMP HUO ISO13485 WENJIANTIXIJIEGOUDEJICHUSHANGBA IVDD DEYAOQIUYOUJIDEJIEHEJINQU

皇冠篮球比分网SHIZHIZAOSHANGYINGKAOLVDEWENTI。YINGJIARUDEWENJIANRUXIABIAOSUOSHI:

皇冠篮球比分网Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


DISIBU

皇冠篮球比分网ZHUNBEI CE JISHUWENJIAN


皇冠篮球比分网IVD ZHILINGZAIDIJIUZHANGFUHEXINGPINGSHENCHENGXUZHONGGUIDING,ZHIZAOSHANGYAOZHUNBEIJISHUWENJIAN,BINGQIEZHEIFENJISHUWENJIANYAOZAIZUI

皇冠篮球比分网HOUYIPICHANPINSHENGCHANHOUZHISHAOBAOCUNWUNIAN,YIBEIJIANCHA。

IVD ZHILINGZAIFULU III ZHONGHENMINGQUEDIMIAOSHULEJISHUWENJIANBAOHANNAXIEWENJIAN。DUIYUZHIZAOSHANGERYAN,SUOYOUDEZHEIXIE

WENJIANDOUSHIZAITIXIYUNXINGZHONGCHANSHENGDE,ERBUSHIZHUANMENBIANXIEDE,ZHIZAOSHANGKEYIGENJUYAOQIU,JIANLIYIFENJISHUWENJIANDEQING

DAN,JIANGSUOXUYAODEWENJIANSHOUJIZAIYIQI,JIUSHIJISHUWENJIANLE。

CE JISHUWENJIANDEQINGDAN

皇冠篮球比分网Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


JIBENYAOQIUJIANCHABIAO

JISHUWENJIANDEHEXINSHIZHENGMINGFUHEJIBENYAOQIUDEZILIAO。GENJU IVDD DI 5 ZHANGDEMIAOSHU, TONGGUOFUHEXIEDIAOBIAOZHUNKE

BEIRENWEIFUHEJIBENYAOQIU。RANERSHIJISHANGBUKENENGSUOYOUYILIAOQIXIEDOUYOUXIEDIAOBIAOZHUN。YINCIRUGUOMEIYOUXIEDIAOBIAOZHUN,ZE

皇冠篮球比分网YINGCAIYONGQITAGUOJIBIAOZHUNZUZHIRU ISO, IEC, DIN, ANSI, AMI HE ASTM DEBIAOZHUN。ZHIZAOSHANGYEKEYICAIYONGJISHUSHANG

RENKEDEFANGFALAIZHENGMINGFUHEJIBENYAOQIU。DANQIANWANXIAOXINCAIYONGJILIJIESHIERBUSHIYIYOUDEBIAOZHUNJIANGHUIDAOZHIGENGWEIXIANGXIDE

JIANCHA, RENZHENGKENENGHUAFEIGENGDUODESHIJIAN。

WENJIANHUAZHENGMINGFUHEJIBENYAOQIUDEFANGFASHICAIYONGJIBENYAOQIUJIANCHABIAO,XITONGDILIECHUMEIXIANGJIBENYAOQIUYIJISUOXUANZE

皇冠篮球比分网DEZHENGMINGFUHEGAIYAOQIUDEFANGFA。ZHEIYANGYIFENJIANCHABIAOKEJIANSHAOZHIZAOSHANG, GONGGAOJIGOUHEZHUGUANDANGJUDEFUDAN。

皇冠篮球比分网ZAI IVD ZHILINGDEFULU I,GUIDINGLEXIAOWANGOUZHOUDETIWAIZHENDUANYILIAOQICAIYINGJUBEIDEZUIDIZHILIANGYAOQIU,GONGYOU 13

皇冠篮球比分网XIANGJIBENYAOQIU, QIZHONGQIAN 5 XIANGWEITONGYONGYAOQIU, DUISUOYOUCHANPINDOUSHIYONG。 HOU 8 XIANGWEIZHUANYONGYAOQIU, YINGGENJUCHANPINDETE

皇冠篮球比分网DIAN, PANDUANSHIFOUSHIYONG, RUBUSHIYONGYEXUSHUOMINGLIYOU。TIANXIEJIBENYAOQIUJIANCHABIAODEJIBENBUZHOUSHI: SHOUXIANPANDUANMEIYITIAO

KUANDUININDECHANPINSHIFOUSHIYONG, RUSHIYONGDEHUASHIFOUYOUSHIYONGDEOUMENGXIEDIAOBIAOZHUNHUOGUOJIBIAOZHUN, BINGTIGONGCHONGFENDEZHENGJUZHENG

皇冠篮球比分网MINGYIMANZULEGAITIAOKUANDEYAOQIU。(RUCHANPINJIANCEBAOGAO, LINCHUANGZILIAOBAOGAO, FENGXIANFENXIBAOGAODENG)。

ZHIZAOSHANGZAITIANXIEJIBENYAOQIUJIANCHABIAOGUOCHENGZHONG,YAOQUERENRENHEYOUGUANDEOUZHOUXIEDIAOBIAOZHUN,DUIYUMOUZHONG IVD LAISHUO,

KENENGYOUDUOZHONGXIEDIAOBIAOZHUNSHIYONGYUTA。YINCIZAIQUERENNAXIEXIEDIAOBIAOZHUNSHIYONGYUMOUZHONGCHANPINSHIYINGSHIFENZIXI。IVDD ZHI

LINGDEXIEDIAOBIAOZHUNQINGDANKEYIZAIOUMENGDEGUANFANGWANGZHANSHANGCHAZHAO,WANGZHISHI:

http://www.newapproach.org/Directives/Default.asp

XIABIAOSHIBUFENYU IVDD ZHILINGXIANGGUANDEXIEDIAOBIAOZHUN:

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


DIWUBU

XUANZEHESHIDEGONGGAOJIGOU


皇冠篮球比分网GONGGAOJIGOUSHIYIGEYOUOUMENGMOUGECHENGYUANGUODEZHUGUANDANGJUZHIDINGDECESHI、SHENHEHERENZHENGJIGOU,TAKECONGSHI IVDD

DEFULUZHONGSUOMIAOSHUDEYIZHONGHUODUOZHONGFUHEXINGPINGJIACHENGXU。GONGGAOJIGOUBIXUWEIYUOUMENGDEMOUGECHENGYUANGUONEI。

皇冠篮球比分网XUANZEGONGGAOJIGOUSHIZHIZAOSHANGMIANLINDEJIQIGUANJIANDEWENTIZHIYI。WEILENENGGOUYOUXIAODIGONGZUOYINGHEGONGGAOJIGOUJIANLIZHANG

皇冠篮球比分网QIHEMIQIEDELIANXI,YINGDUIFEICHANGSHENZHONGDIXUANZEGONGGAOJIGOU。MUQIAN,YOUDUOJIAGONGGAOJIGOUZAIGUONEIDEDAIBIAOCHUKAIZHANCIFANG

皇冠篮球比分网MIANYEWU,YIBANLAISHUO,ZHIZAOSHANGZAIXUANZEGONGGAOJIGOUDESHIHOU,YINGKAOLVXIALIEYINSU。DIYI,GONGGAOJIGOUBEIOUMENGSHOUQUAN

DE IVDD RENZHENGFANWEI、BEISHOUQUANDEKEJINXINGDEFUHEXINGPINGJIACHENGXU,RUMOUXIEGONGGAOJIGOUMEIYOU List A CHANPINDERENZHENGZI

皇冠篮球比分网GE。DIER,GONGGAOJIGOUBENDIDESHENHEYUANZIYUAN。RUGUOGONGGAOJIGOUZAIGUONEIMEIYOUJUYOU IVDD SHENHEZIGEDESHENHEYUAN,

BIRANHUIZAOCHENGZHIZAOSHANGYUGONGGAOJIGOUDEGOUTONGBUBIAN,FEIYONGYEJIANGCHENGBEIZENGJIA。

皇冠篮球比分网ZHIZAOSHANGXUANZEHAOHESHIDEGONGGAOJIGOUHOU,GONGGAOJIGOUJIANGDUIZHIZAOSHANGJINXINGWENJIANSHENHEHEXIANCHANGSHENHE,GENJUSHENHEFA

XIAN,JUEDINGSHIFOUBANFA CE ZHENGSHU。QIZHONG List A、List B HEZIWOJIANCEDE IVD CHANPINXUYAOGONGGAOJIGOUSHENHEFAZHENG,

CE Mark DEHOUMIANHUOXIAMIANBIXUBIAOSHANGGAIJIGOUDEDAIMA,RU

0843

GAI CE BIAOZHIZHONGDE 0843 JIUSHI UL-UK ZHEIGEGONGGAOJIGOUDEDAIMA。


DILIUBU

HUODE CE ZHENGSHUJIZHUCE


ZHIZAOSHANGZAIHUODEGONGGAOJIGOUDE CE ZHENGSHUHOU,BINGBUNENGPINGZHEIZHANGZHENGSHUJIUJIANGCHANPINMAIDAOOUMENGDECHENGYUANGUO,GENJU

IVD ZHILINGDEDI 10 ZHANGZHONGGUIDING,ZHIZAOSHANGHAIYAOQUCHENGYUANGUODEZHUGUANDANGJU(competent authorities)QUZHUCE,HUO

WEITUOOUMENGDAIBIAOQUBANGZHUZHIZAOSHANGWANCHENGZHUCE。RUGUOZHIZAOSHANGDECHANPINZAINAYIGEOUMENGCHENGYUANGUOXIAOSHOU,JIUXUYAOXIANZAIZHEI

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com


GECHENGYUANGUOZHUCE。RUGUOZHIZAOSHANGHUODEGONGGAOJIGOUDE CE ZHENGSHUHOU,MEIYOUZHUCE,JIUZAIOUMENGCHENGYUANGUONEIMAICHANPINSHIFEI

FADEXINGWEI。


DIQIBU

List A CHANPINDEPIPIJIAN


皇冠篮球比分网ZAI IVD ZHILINGDEFULU IV.6 HEFULU VII.5 ZHONGDOUGUIDINGLE List A CHANPINDEPIYANZHENGYAOQIU(CHUCIZHIWAIDEQITALEI

皇冠篮球比分网CHANPINWUCIYAOQIU),LEISIWOGUO SFDA DEPIPIJIAN。IVD ZHILINGZHIZAOSHANGZAIMEIPICHANPINZHIZAOJIANYANHEGEHOULIJICHOU

YANG,ANSHIXIANHEGONGGAOJIGOUDEYUEDING,JIANGYANGPINSONGJIAOGONGGAOJIGOUJIANYAN,GONGGAOJIGOUBIXUZAIGUIDINGDESHIJIANNEIZUOCHUHUI

FU,DANBUKECHAOGUO 30 TIAN,QUEDINGGAIPICHANPINSHIFOUKEYIDASHANG CE BIAOJI。


DIBABU

SHICHANGHOUJIANDUHEJINGJIEXITONG


TIWAIZHENDUANYILIAOQICAIDESHANGSHIHOUJIANDU,YUYILIAOQICAIXIANGTONG,SHIBAOHANYUZHENGGEOUMENGDEYILIAOQICAIJINGJIEXITONG

ZHONG,GEHUIYUANGUODEWEISHENGQUANZEJIGUANYAOFUZEQUEBAOGAIGUANXIAQUYUNEIDECHANPINZHILIANG,FUYOUTONGBAO、QUDIDEZEREN,GEGUO

皇冠篮球比分网DEZHUGUANDANGJU(competent authorities)YEYOUYIWUYAODINGQIPINGGUGUONEISHANGSHIQICAIDEZHILIANG,TEBIESHIFULU II SUO

皇冠篮球比分网LIEJUDECHANPINXIANGMU,BUGUANSHIQICAIDEFUZUOYONG、CHANPINSHIXIAOHUOCUZHILANZAOSUOZAOCHENGDE,YIDANZHIJIEHUOJIANJIEWEIJIBING

皇冠篮球比分网HUAN、SHIYONGZHEHUOQITARENYUANDESHENGMINGHUOJIANKANG,ZHUGUANDANGJUBIXUZELINGLIJIZHIZAOSHANGCAIQUXINGDONGRUZHAOHUI、TONGBAO,CHANPIN

DEZHILIANGWENTICHULEGONGNENGZHIWAI,HAIBAOHANBIAOSHI、BIAOQIANHUOSHIYONGSHUOMINGDEBUDANGYUCUOWU。

GEHUIYUANGUODEZHUGUANDANGJUJIANGZAIOUMENGDEXITONGZHIXIAJIANLIYIGEOUZHOUSHUJUKU(European Databank),QUEBAOGE

HUIYUANGUOQIESHIZHANGWOCHANPINDEDONGTAIXINXI,ZAITIWAIZHENDUANJIYIBANYILIAOQICAIFANGMIAN,SHUJUKUJIANGHUIBAOHANZHIZAOSHANGYUQICHAN

皇冠篮球比分网PINDEZHUCESHUJU、CHANPINYANZHENGDEXIUZHENG、BUCHONG、GEZHI、CHEHUIHUOZHONGZHIDENGXINXI、CHANPINSHIXIAO、SHANGHAIHUOZHAOHUIDEXINXI

DENG。QUEBAOQUANOUDETIWAIZHENDUANYILIAOQICAIDOUZAIGEHUIYUANGUOZHUGUANDANGJUDEZHANGWOZHIZHONG。

WEICI,ZHIZAOSHANGYAOZHIDINGZHUANMENDESHICHANGHOUJIANDUCHENGXUYIJIJINGJIEXITONG,WEILEBAOZHENGNENGSUISHIQIDONGGAIXITONG,XUYAO

DINGQIJINXINGYANXILAIYANZHENG。


SAN.

XIANGGUANWANGZHAN


OUMENGYILIAOQIXIEGUANFANGWANGZHAN

http://europa.eu.int/comm/enterprise/medical_devices/

OUMENGZHILINGGUANFANGWANGZHAN

皇冠篮球比分网http://www.newapproach.org/Directives/Default.asp

YILIAOQIXIEGUOJIXIEDIAOTEWEIHUI

皇冠篮球比分网http://www.ghtf.org/

FDA YILIAOQIXIEGUANFANGWANGZHAN

http://www.fda.gov/cdrh/

Edited by Stephen Ling. Any question, please contact me via email: info@cefda.com

更多
收起
    服务流程资料添加中....
    官方收费资料添加中....
    基础法规资料添加中....
    相关服务资料添加中....

    体外诊断医疗器材申请 CE 认证指南

    体外诊断试剂CE认证技术文件清单

    IVDD服务途径

全国服务热线:

400-9905-168

关注我们

广州格慧泰福(GHTF)生物科技有限公司 版权所有