澳门百家乐玩法

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       美國FDA(Food  and  Drug  Admistraton簡稱FDA)即美國食品藥品管理局,隸屬于美國衛生教育福利部,有人說相當于中國的國家藥品監督管理局,其實是不確切的。準確地說,美國FDA是相當于我國的衛生部(負責保健食品的審批)和國家藥品監督管理局(負責藥品的審批)兩個行業管理機構。它負責美國全國藥品、食品、生物制品、化妝品、獸藥、Yliao器械以及診斷用品等的管理并致力于保護、促進和提高國民的健康,確保美國市場上銷售的食品、藥品、化妝品和Yliao器具對人體的安全性、有效性.

澳门百家乐玩法   FDAXIASHEYAOPINJU、SHIPINJU、SHOUYAOJU、FANGSHEWEISHENGJU、SHENGWUZHIPINJU、YliaoQIXIEJIZHENDUANYONGPINJUHEGUOJIADULIYANJIUZHONGXIN、QUYUGONGZUOGUANLIJIGOU,JI6GEJU(YOUDEKANWUYECHENG6GEZHONGXIN),YIGEZHONGXINHEYIGEQUYUGUANLIJIGOU.

  FDA的范圍:

  XSHEXIANZHENDUANLEIYliaoCHANPIN(YIBANYONGTU,YINGGUANGXSHEXIAN、CTDENG)

澳门百家乐玩法   SHOUSHULEIJIQITAJIGUANGSHEBEIHEYOUJIGUANGDANYUANDESHEBEI

澳门百家乐玩法   TESHUYONGTUDEJIGUANGCHANPIN(BAOKUOXIANSHI、GUANCHAHEYIYONG)

澳门百家乐玩法   ZIWAIXIANZHILIAOSHEBEI(YliaoYONGZIWAIXIANDENGHECHANPIN)

  FEIWULIZHILIAOHEZHENDUANDEQITAYIYONGCHAOSHENGSHEBEI

澳门百家乐玩法   WEIBOTOUREZHILIAOHEWEIBOXUEYEJIAREQI

澳门百家乐玩法   CHAOSHENGWULIZHILIAOSHEBEI

  有電離輻射的電子產品:

  CRTXIANSHIFANGSHIDEDIANSHIJIHESHIPINXIANSHIQI

  有非電離輻射的電子產品

  WEIBOLU

  TAIYANGDENGHETAIYANGDENGCHANPIN(TAIYANGCHUANG)

澳门百家乐玩法   FENGWOSHIYIDONGDIANHUA

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

澳门百家乐玩法   YOUFANGHUWAIKEDEXSHEXIANSHEBEI(LIRUXSHEXIANJIANCHAXITONG,XSHEXIANCHENGXIANGXITONG,XSHEXIANANQUANJIANCHAXITONG,XSHEXIANXINGLIJIANCHAXITONG)

美國FDA認證

  工業和科研產品:

  JIGUANGGONGJUHEJIGUANGYIQI

  FEIYliaoZHENDUANYONGXSHEXIANSHEBEI

  SHEPINHEWEIBOCHANPIN(FEIWEIBOLU)

  FEIZHENDUANHEZHILIAOYONGDECHAOSHENGCHANPIN

  FDA對食品藥品和設備實行兩類管理,即:批準(Approved)和通告澳门百家乐玩法(notification)

  YIiao產品管理分類:

  IJI——ZHELEICHANPINDUISHIYONGZHECHANSHENGDEWEIXIANBUDA,SHEJISHANGTONGCHANGYEBIIIJIHEIIIJIJIANDAN,RUGUANCHANGJI。  47%DEYliaoCHANPINSHUYUZHEYIJI,QIZHONGDE95%BUXUYAOFAGUIGUANLI。

澳门百家乐玩法   IIJI——DUOSHUDEYliaoCHANPINSHUYUIIJI,SHUYUIIJIDECHANPINZHAN43%,LIRUDIANDONGLUNYI、YUNFUYONGPIN。

  IIIJI——ZHEYIJIBIEDECHANPINTONGCHANGYONGLAIWEICHIHUOZHICHIRENDESHENGMING,SHIYONGZHONGHUIDUIRENZAOCHENGQIANZAIDEWEIHAIHUOSHANGHAI。LIRU:ZHIRUSHIXINZANGQIBOQI,FENGRUTIANCHONGWUDENG,YOU10%DEYliaoCHANPINSHUYUIIIJI。

  DUIYUILEICHANPIN,QIZHONGDE95%SHUYUMIANCHUGUANLIDEYliaoSHEBEI,CHANPINZAITOUFANGSHICHANGQIANBUYAOQIUBANLITONGGAO(notification)HUOXUKEZHENG(clearance)SHOUXU。DANSHIYAOQIUZHIZAOSHANGZAIFDAJINXINGJIGOUDENGJI,BINGLIECHUQIZHUYAOCHANPIN。ZHELEIGUANLIDECHANPINLIRURENGONGTINGZHENQI,SHUIYINTIWENBIAO,ZUOBIANQIDENG。

  釋放輻射(非核能)電子產品FDA認證介紹:

澳门百家乐玩法   DUOSHUJINKOUCHUSHANGZHIDAOFDAWEIMEIGUOGUANLISHIPIN、YAOPIN、HUAZHUANGPIN、YliaoQICAIDEZHUGUANJIGUAN,DANYOUSHIHENDUORENQUESHUHULESHIFANGFUSHEDIANZICHANPIN(radiation  emitting  product)YIWEIGAISHUGUIFANCHANPINZHIYI。

澳门百家乐玩法   FDAGUIFANfSHIFANGFUSHEDIANZICHANPINZHIFAYUANWEI「LIANBANGSHIWU、YAOPINYUHUAZHUANGPINFA」DIWUPIANDI531-542TIAO(FEDERAL  FOOD,  DRUG,  AND  COSMETIC  ACT,JIANCHENGWEIFD&C)。

  SUOWEIDESHIFANGFUSHEZHIDIANZICHANPIN,BAOKUODIANSHITIANXIANYUPINGMU、WEIBOLU、ZHENDUANYONGXGUANGSHEBEIJISHIYONGXGUANGHUOJIGUANGXIANGGUANCHANPIN(RUGUANGQUJIJIGUANGZHISHIQI(laser  pointer))DENG。

澳门百家乐玩法   DUOSHUSHIFANGFUSHEDIANZICHANPINBINGBUHUIRENDINGWEIYliaoQICAI,WEIRUOZHIZAOHUOJINGXIAOSHANGXUANCHENGGAICHANPINYOUYliaoGONGNENGSHI,GAICHANPINBINGXUFUHEFDAYOUGUANYliaoQICAIZHIGUIFAN。GUOHUILIFAGUIFANSHIFANGFUSHEZHIDIANZICHANPINZHUYAOLIYOUZAIYUFANGZHIXIAOFEIZHEYINSHIYONGGAILEICHANPINDUIJIANKANGZAOCHENGZHIYINGXIANG。

澳门百家乐玩法   YIJIGUANGXIANGGUANCHANPINWEILI,WOGUOCHUKOUZHULICHANPINGUANGQUBIANXUYAOFUHEFDAZHIGUIFAN,LINGWAIHANGUANGQUZHICHANPINYIZAIGUIFANZHILIE,RUBIJIBENJISUANJI。YIGUANGQUERYAN,FDAYIJUQIFUSHELIANGDAXIAOFENWEISILEI,YIBANXIAOFEIZHESHIYONGZHIGUANGQUSUOHANJIGUANGDUOSHUYUWEIXIANXINGJIAODIDEDIYILEI(class  1)。DIYILEIGUANGQUXIAOMEIQIAN,YEZHEBIXUFUHEFDAYIXIAGUIDING:

  1、ZIWOFUHEXUANSHIBIAO;

  2、CHANPINDENGJI;

  3、CESHIBIAOZHUN;

澳门百家乐玩法   4、CHANPINBAOGAO(Product  Reports);

  5、NIANDUBAOGAO(Annual  Reports);

澳门百家乐玩法   NIANDUBAOGAOYINGYUMEINIANJIUYUEYIRIYOUJIZHIFDA,RUWEIDINGQIGENGXIN,CHANPINTONGGUANSHIJIANGBEIHAIGUANKOULIU。RUGUOYEZHEYINSHUHUWEIJISHIYOUJIGAIBAOGAOERZAOCHENGCHANPINBEIKOULIU,MEIHAIGUANKEJIESHOUYEZHEBUJIXIANGGUANZILIAOHOUYUYITONGGUAN。

澳门百家乐玩法   6、CESHIJILU;

  7、XIANGGUANJILU;

  8、JINGSHIBIAOZHIGUIDING;

  FDARENZHENGLIUCHENG

  1. ZHUNBEIJIEDUAN

  QIYEFARENZHIZHAOFUYINJIAN;

  SHENGCHAN(WEISHENG)XUKEZHENG,HEGEZHENGFUYINJIAN;

澳门百家乐玩法   QIYEJIANJIE(CHENGLISHIJIAN,JISHULILIANG,ZHUYAOCHANPINJIQIXINGNENG,ZICHANZHUANGKUANG)。

澳门百家乐玩法   2. JISHUCHUSHENSHENBAOSHOULI

  DIJIAODMF(YAOWUZHUWENJIAN)HESOP(BIAOZHUNCAOZUOCHENGXU)DEYINGYIBENWENJIANGEIDAILISHANG;

  GENJUDAILISHANGDEYIJIAN,DUISHANGSHUWENJIANJINXINGXIUGAI。

澳门百家乐玩法   3. DMFZILIAOSHENYUE

  FDARENZHENSHENHE,BINGDAOGONGCHANGSHIDIKAOCHA,JIANCHADMFWENJIANSUOXIESHIFOUSHUSHI;

  RUOFDAWEIFAXIANZHONGDACHACUO,BINGRENWEIFUHEYAOQIU,ZETICHUYUPIZHUNJIANCHAJIHUA。

  4. FDAJIANCHA

澳门百家乐玩法   FDAJIANCHAGUANDUIGONGCHANGJINXINGJIANCHA,TIWEN,GONGCHANGBIXUYIYIHUIDA;

  RUOYOUYIWEN,GUANYUANHUIGEICHU“483”BIAO(ZHENGGAIJIANYISHU),WENTIYANZHONG,ZEBUGEI“483”BIAO。

  5. FDAQIANFA“PIZHUNXIN”

  BIXURENZHENHUIDA“483”BIAOSHANGJIANCHAGUANTICHUDEWENTI,RUOYOUWENTI,BIXULIJIGAIZHENGBINGZHENGMING;

  JIANCHAGUANWEIGAOQINGCHUDEWENTI,XUJIESHIZHENGMING

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