159彩票注册

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       美国FDA(Food  and  Drug  Admistraton简称FDA)即美国食品药品管理局,隶属于美国卫生教育福利部,有人说相当于中国的国家药品监督管理局,其实是不确切的。准确地说,美国FDA是相当于我国的卫生部(负责保健食品的审批)和国家药品监督管理局(负责药品的审批)两个行业管理机构。它负责美国全国药品、食品、生物制品、化妆品、兽药、Yliao器械以及诊断用品等的管理并致力于保护、促进和提高国民的健康,确保美国市场上销售的食品、药品、化妆品和Yliao器具对人体的安全性、有效性.

  FDAXIASHEYAOPINJU、SHIPINJU、SHOUYAOJU、FANGSHEWEISHENGJU、SHENGWUZHIPINJU、YliaoQIXIEJIZHENDUANYONGPINJUHEGUOJIADULIYANJIUZHONGXIN、QUYUGONGZUOGUANLIJIGOU,JI6GEJU(YOUDEKANWUYECHENG6GEZHONGXIN),YIGEZHONGXINHEYIGEQUYUGUANLIJIGOU.

  FDA的范围:

159彩票注册   XSHEXIANZHENDUANLEIYliaoCHANPIN(YIBANYONGTU,YINGGUANGXSHEXIAN、CTDENG)

159彩票注册   SHOUSHULEIJIQITAJIGUANGSHEBEIHEYOUJIGUANGDANYUANDESHEBEI

159彩票注册   TESHUYONGTUDEJIGUANGCHANPIN(BAOKUOXIANSHI、GUANCHAHEYIYONG)

  ZIWAIXIANZHILIAOSHEBEI(YliaoYONGZIWAIXIANDENGHECHANPIN)

  FEIWULIZHILIAOHEZHENDUANDEQITAYIYONGCHAOSHENGSHEBEI

159彩票注册   WEIBOTOUREZHILIAOHEWEIBOXUEYEJIAREQI

159彩票注册   CHAOSHENGWULIZHILIAOSHEBEI

  有电离辐射的电子产品:

  CRTXIANSHIFANGSHIDEDIANSHIJIHESHIPINXIANSHIQI

  有非电离辐射的电子产品

  WEIBOLU

  TAIYANGDENGHETAIYANGDENGCHANPIN(TAIYANGCHUANG)

  FENGWOSHIYIDONGDIANHUA

  JIGUANGCHANPIN:BAOKUOJIGUANGBI,JIGUANGYANSHI,JIGUANGXIANSHI,HANYOUJIGUANGDANYUANDECHANPIN(CDBOFANGJI,DVD,CD-ROM,JIGUANGDAYINJIDENG)  ANQUANFANGHUHEJIUHUCHANPIN

  YOUFANGHUWAIQIAODEXSHEXIANSHEBEI(LIRUXSHEXIANJIANCHAXITONG,XSHEXIANCHENGXIANGXITONG,XSHEXIANANQUANJIANCHAXITONG,XSHEXIANXINGLIJIANCHAXITONG)

美国FDA认证

  工业和科研产品:

159彩票注册   JIGUANGGONGJUHEJIGUANGYIQI

  FEIYliaoZHENDUANYONGXSHEXIANSHEBEI

  SHEPINHEWEIBOCHANPIN(FEIWEIBOLU)

159彩票注册   FEIZHENDUANHEZHILIAOYONGDECHAOSHENGCHANPIN

  FDA对食品药品和设备实行两类管理,即:批准(Approved)和通告(notification)

  YIiao产品管理分类:

159彩票注册   IJI——ZHEILEICHANPINDUISHIYONGZHECHANSHENGDEWEIXIANBUDA,SHEJISHANGTONGCHANGYEBIIIJIHEIIIJIJIANDAN,RUGUANCHANGJI。  47%DEYliaoCHANPINSHUYUZHEIYIJI,QIZHONGDE95%BUXUYAOFAGUIGUANLI。

159彩票注册   IIJI——DUOSHUDEYliaoCHANPINSHUYUIIJI,SHUYUIIJIDECHANPINZHAN43%,LIRUDIANDONGLUNYI、YUNFUYONGPIN。

159彩票注册   IIIJI——ZHEIYIJIBIEDECHANPINTONGCHANGYONGLAIWEICHIHUOZHICHIRENDESHENGMING,SHIYONGZHONGHUIDUIRENZAOCHENGQIANZAIDEWEIHAIHUOSHANGHAI。LIRU:ZHIRUSHIXINZANGQIBOQI,FENGRUTIANCHONGWUDENG,YOU10%DEYliaoCHANPINSHUYUIIIJI。

159彩票注册   DUIYUILEICHANPIN,QIZHONGDE95%SHUYUMIANCHUGUANLIDEYliaoSHEBEI,CHANPINZAITOUFANGSHICHANGQIANBUYAOQIUBANLITONGGAO(notification)HUOXUKEZHENG(clearance)SHOUXU。DANSHIYAOQIUZHIZAOSHANGZAIFDAJINXINGJIGOUDENGJI,BINGLIECHUQIZHUYAOCHANPIN。ZHEILEIGUANLIDECHANPINLIRURENGONGTINGZHENQI,SHUIYINTIWENBIAO,ZUOBIANQIDENG。

  释放辐射(非核能)电子产品FDA认证介绍:

  DUOSHUJINKOUCHUSHANGZHIDAOFDAWEIMEIGUOGUANLISHIPIN、YAOPIN、HUAZHUANGPIN、YliaoQICAIDEZHUGUANJIGUAN,DANYOUSHIHENDUORENQUESHUHULESHIFANGFUSHEDIANZICHANPIN(radiation  emitting  product)YIWEIGAISHUGUIFANCHANPINZHIYI。

  FDAGUIFANfSHIFANGFUSHEDIANZICHANPINZHIFAYUANWEI「LIANBANGSHIWU、YAOPINYUHUAZHUANGPINFA」DIWUPIANDI531-542TIAO(FEDERAL  FOOD,  DRUG,  AND  COSMETIC  ACT,JIANCHENGWEIFD&C)。

159彩票注册   SUOWEIDESHIFANGFUSHEZHIDIANZICHANPIN,BAOKUODIANSHITIANXIANYUPINGMU、WEIBOLU、ZHENDUANYONGXGUANGSHEBEIJISHIYONGXGUANGHUOJIGUANGXIANGGUANCHANPIN(RUGUANGQUJIJIGUANGZHISHIQI(laser  pointer))DENG。

159彩票注册   DUOSHUSHIFANGFUSHEDIANZICHANPINBINGBUHUIRENDINGWEIYliaoQICAI,WEIRUOZHIZAOHUOJINGXIAOSHANGXUANCHENGGAICHANPINYOUYliaoGONGNENGSHI,GAICHANPINBINGXUFUHEFDAYOUGUANYliaoQICAIZHIGUIFAN。GUOHUILIFAGUIFANSHIFANGFUSHEZHIDIANZICHANPINZHUYAOLIYOUZAIYUFANGZHIXIAOFEIZHEYINSHIYONGGAILEICHANPINDUIJIANKANGZAOCHENGZHIYINGXIANG。

159彩票注册   YIJIGUANGXIANGGUANCHANPINWEILI,WOGUOCHUKOUZHULICHANPINGUANGQUBIANXUYAOFUHEFDAZHIGUIFAN,LINGWAIHANGUANGQUZHICHANPINYIZAIGUIFANZHILIE,RUBIJIBENJISUANJI。YIGUANGQUERYAN,FDAYIJUQIFUSHELIANGDAXIAOFENWEISILEI,YIBANXIAOFEIZHESHIYONGZHIGUANGQUSUOHANJIGUANGDUOSHUYUWEIXIANXINGJIAODIDEDIYILEI(class  1)。DIYILEIGUANGQUXIAOMEIQIAN,YEZHEBIXUFUHEFDAYIXIAGUIDING:

159彩票注册   1、ZIWOFUHEXUANSHIBIAO;

  2、CHANPINDENGJI;

  3、CESHIBIAOZHUN;

  4、CHANPINBAOGAO(Product  Reports);

  5、NIANDUBAOGAO(Annual  Reports);

  NIANDUBAOGAOYINGYUMEINIANJIUYUEYIRIYOUJIZHIFDA,RUWEIDINGQIGENGXIN,CHANPINTONGGUANSHIJIANGBEIHAIGUANKOULIU。RUGUOYEZHEYINSHUHUWEIJISHIYOUJIGAIBAOGAOERZAOCHENGCHANPINBEIKOULIU,MEIHAIGUANKEJIESHOUYEZHEBUJIXIANGGUANZILIAOHOUYUYITONGGUAN。

  6、CESHIJILU;

  7、XIANGGUANJILU;

159彩票注册   8、JINGSHIBIAOZHIGUIDING;

159彩票注册   FDARENZHENGLIUCHENG

  1. ZHUNBEIJIEDUAN

159彩票注册   QIYEFARENZHIZHAOFUYINJIAN;

  SHENGCHAN(WEISHENG)XUKEZHENG,HEGEZHENGFUYINJIAN;

  QIYEJIANJIE(CHENGLISHIJIAN,JISHULILIANG,ZHUYAOCHANPINJIQIXINGNENG,ZICHANZHUANGKUANG)。

  2. JISHUCHUSHENSHENBAOSHOULI

  DIJIAODMF(YAOWUZHUWENJIAN)HESOP(BIAOZHUNCAOZUOCHENGXU)DEYINGYIBENWENJIANJIDAILISHANG;

159彩票注册   GENJUDAILISHANGDEYIJIAN,DUISHANGSHUWENJIANJINXINGXIUGAI。

  3. DMFZILIAOSHENYUE

  FDARENZHENSHENHE,BINGDAOGONGCHANGSHIDIKAOCHA,JIANCHADMFWENJIANSUOXIESHIFOUSHUSHI;

  RUOFDAWEIFAXIANZHONGDACHACUO,BINGRENWEIFUHEYAOQIU,ZETICHUYUPIZHUNJIANCHAJIHUA。

  4. FDAJIANCHA

  FDAJIANCHAGUANDUIGONGCHANGJINXINGJIANCHA,TIWEN,GONGCHANGBIXUYIYIHUIDA;

  RUOYOUYIWEN,GUANYUANHUIJICHU“483”BIAO(ZHENGGAIJIANYISHU),WENTIYANZHONG,ZEBUJI“483”BIAO。

  5. FDAQIANFA“PIZHUNXIN”

  BIXURENZHENHUIDA“483”BIAOSHANGJIANCHAGUANTICHUDEWENTI,RUOYOUWENTI,BIXULIJIGAIZHENGBINGZHENGMING;

159彩票注册   JIANCHAGUANWEIGAOQINGCHUDEWENTI,XUJIESHIZHENGMING

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