欧洲杯预测

簡介

欧洲杯预测 meiguofda(food and drug admistratonjianchengfda)jimeiguoshipinyaopinguanliju,lishuyumeiguoweishengjiaoyufulibu,yourenshuoxiangdangyuzhongguodeguojiayaopinjianduguanliju,qishishibuqueqiede。zhunquedishuo,meiguofdashixiangdangyuwoguodeweishengbu(fuzebaojianshipindeshenpi)heguojiayaopinjianduguanliju(fuzeyaopindeshenpi)lianggexingyeguanlijigou。tafuzemeiguoquanguoyaopin、shipin、shengwuzhipin、huazhuangpin、shouyao、yliaoqixieyijizhenduanyongpindengdeguanlibingzhiliyubaohu、cujinhetigaoguomindejiankang,quebaomeiguoshichangshangxiaoshoudeshipin、yaopin、huazhuangpinheyliaoqijuduirentideanquanxing、youxiaoxing.fdaxiasheyaopinju、shipinju、shouyaoju、fangsheweishengju、shengwuzhipinju、yliaoqixiejizhenduanyongpinjuheguojiaduliyanjiuzhongxin、quyugongzuoguanlijigou,ji6geju(youdekanwuyecheng6gezhongxin),yigezhongxinheyigequyuguanlijigou.

FDA的范圍

yiliaochanpin

—xshexianzhenduanleiyliaochanpin(yibanyongtu,yingguangxshexian、ctdeng)

欧洲杯预测 —shoushuleijiqitajiguangshebeiheyoujiguangdanyuandeshebei

欧洲杯预测 —teshuyongtudejiguangchanpin(baokuoxianshi、guanchaheyiyong)

—ziwaixianzhiliaoshebei(yliaoyongziwaixiandenghechanpin)

—feiwulizhiliaohezhenduandeqitayiyongchaoshengshebei

—weibotourezhiliaoheweiboxueyejiareqi

—chaoshengwulizhiliaoshebei

有電離輻射的電子產品

欧洲杯预测 —crtxianshifangshidedianshijiheshipinxianshiqi

有非電離輻射的電子產品

—weibolu —taiyangdenghetaiyangdengchanpin(taiyangchuang) —fengwoshiyidongdianhua —jiguangchanpin:baokuojiguangbi,jiguangyanshi,jiguangxianshi,hanyoujiguangdanyuandechanpin(cdbofangji,dvd,cd-rom,jiguangdayinjideng) anquanfanghuhejiuhuchanpin —youfanghuwaikedexshexianshebei(liruxshexianjianchaxitong,xshexianchengxiangxitong,xshexiananquanjianchaxitong,xshexianxinglijianchaxitong)

工業和科研產品

—jiguanggongjuhejiguangyiqi —feiyliaozhenduanyongxshexianshebei —shepinheweibochanpin(feiweibolu) —feizhenduanhezhiliaoyongdechaoshengchanpin fdaduishipinyaopinheshebeishixingliangleiguanli,ji:pizhun(approved)hetonggao(notification)

醫療產品管理分類

欧洲杯预测 iji——zheleichanpinduishiyongzhechanshengdeweixianbuda,shejishangtongchangyebiiijiheiiijijiandan,ruguanchangji。 47%deyliaochanpinshuyuzheyiji,qizhongde95%buxuyaofaguiguanli。 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

duoshujinkouchushangzhidaofdaweimeiguoguanlishipin、yaopin、huazhuangpin、yliaoqicaidezhuguanjiguan,danyoushihenduorenqueshuhuleshifangfushedianzichanpin(radiation emitting product)yiweigaishuguifanchanpinzhiyi。 fdaguifanfshifangfushedianzichanpinzhifayuanwei「lianbangshiwu、yaopinyuhuazhuangpinfa」diwupiandi531-542tiao(federal food, drug, and cosmetic act,jianchengweifd&c)。 suoweideshifangfushezhidianzichanpin,baokuodianshitianxianyupingmu、weibolu、zhenduanyongxguangshebeijishiyongxguanghuojiguangxiangguanchanpin(ruguangqujijiguangzhishiqi(laser pointer))deng。 duoshushifangfushedianzichanpinbingbuhuirendingweiyliaoqicai,weiruozhizaohuojingxiaoshangxuanchenggaichanpinyouyliaogongnengshi,gaichanpinbingxufuhefdayouguanyliaoqicaizhiguifan。guohuilifaguifanshifangfushezhidianzichanpinzhuyaoliyouzaiyufangzhixiaofeizheyinshiyonggaileichanpinduijiankangzaochengzhiyingxiang。 yijiguangxiangguanchanpinweili,woguochukouzhulichanpinguangqubianxuyaofuhefdazhiguifan,lingwaihanguangquzhichanpinyizaiguifanzhilie,rubijibenjisuanji。yiguangqueryan,fdayijuqifusheliangdaxiaofenweisilei,yibanxiaofeizheshiyongzhiguangqusuohanjiguangduoshuyuweixianxingjiaodidediyilei(class 1)。diyileiguangquxiaomeiqian,yezhebixufuhefdayixiaguiding: 1、ziwofuhexuanshibiao; 2、chanpindengji; 3、ceshibiaozhun; 4、chanpinbaogao(product reports); 5、niandubaogao(annual reports); niandubaogaoyingyumeinianjiuyueyiriyoujizhifda,ruweidingqigengxin,chanpintongguanshijiangbeihaiguankouliu。ruguoyezheyinshuhuweijishiyoujigaibaogaoerzaochengchanpinbeikouliu,meihaiguankejieshouyezhebujixiangguanziliaohouyuyitongguan。 6、ceshijilu; 7、xiangguanjilu; 8、jingshibiaozhiguiding;

FDA認證流程

1. zhunbeijieduan qiyefarenzhizhaofuyinjian; shengchan(weisheng)xukezheng,hegezhengfuyinjian; qiyejianjie(chenglishijian,jishuliliang,zhuyaochanpinjiqixingneng,zichanzhuangkuang)。 2. jishuchushenshenbaoshouli dijiaodmf(yaowuzhuwenjian)hesop(biaozhuncaozuochengxu)deyingyibenwenjiangeidailishang; genjudailishangdeyijian,duishangshuwenjianjinxingxiugai。 3. dmfziliaoshenyue fdarenzhenshenhe,bingdaogongchangshidikaocha,jianchadmfwenjiansuoxieshifoushushi; ruofdaweifaxianzhongdachacuo,bingrenweifuheyaoqiu,zetichuyupizhunjianchajihua。 4. fdajiancha fdajianchaguanduigongchangjinxingjiancha,tiwen,gongchangbixuyiyihuida; ruoyouyiwen,guanyuanhuigeichu“483”biao(zhenggaijianyishu),wentiyanzhong,zebugei“483”biao。 5. fdaqianfa“pizhunxin” bixurenzhenhuida“483”biaoshangjianchaguantichudewenti,ruoyouwenti,bixulijigaizhengbingzhengming; jianchaguanweigaoqingchudewenti,xujieshizhengming

模板1

moban2

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