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FDA认证是什么,如何获得FDA认证?

浏览次数: | 2018-06-13 09:23

亿博CE认证机构一个专业全面的、经验丰富的认证服务机构,已有超过十年的检测认证经验,拥有资深技术团队为您提供全方位检测认证需求,服务热线:135-4327-2595


       MEIGUOSHIPINHEYAOWUGUANLIJU(Food and Drug Administration)JIANCHENGFDA,FDA SHIMEIGUOZHENGFUZAIJIANKANGYURENLEIFUWUBU (DHHS) HEGONGGONGWEISHENGBU (PHS) ZHONGSHELIDEZHIXINGJIGOUZHIYI。ZUOWEIYIJIAKEXUEGUANLIJIGOU,FDA DEZHIZESHIQUEBAOMEIGUOBENGUOSHENGCHANHUOJINKOUDESHIPIN、HUAZHUANGPIN、YAOWU、SHENGWUZHIJI、YILIAOSHEBEIHEFANGSHECHANPINDEANQUAN。TASHIZUIZAOYIBAOHUXIAOFEIZHEWEIZHUYAOZHINENGDELIANBANGJIGOUZHIYI。

FDA认证

  1. Application Form

  SHENQINGBIAO:BAOHANGONGSIXINXI,CHANPINXINXIDENG

  2. Product File / Technology Specification

  CHANPINWENJIAN/JISHUZILIAO:ZHUYAOBAOKUOZHUNBEIXIANGXIDESHUOMINGSHU/XIAOSHOUSHOUCE、ANZHUANGSHOUCE、WEIHUSHOUCEDENG;CHANPINZHUANGPEITU;YIJICHANPINJISHUXINXI,YOUWUJIGUANGFANGHUCUOSHIJIQIGONGZUOYUANLIMIAOSHU。

亚博全站   3. Label

亚博全站   BIAOQIAN:FUHEGUIDINGDEYINGWENBIAOQIAN,HANJINGGAOBIAOZHIDEJINGSHIBIAOQIAN、CHANPINBIAOQIAN、FUHEXINGRENZHENGBIAOQIAN(RUComplies with 21 CFR 1040.10 & 1040.11)、JICHUGUANGKOUBIAOSHIBIAOQIANDENGDENG。

  4. Laser Information

亚博全站   JIGUANGQIJIANXINXI:JIGUANGFASHENGQIDELEIXING、JIEZHI、JIGUANGGUANGLUTU、JIGUANGCANSHU、JIGUANGQIJIANHEGEZHENG/CESHIJILU(RUOCAIGOUZIQITACHANGJIA,XUYAOTIGONGGAICHANGJIADEXINXI、JIGUANGQIJIANCANSHU/DatasheetHUOSHUOMINGSHU、JIGAIJIGUANGQIJIANYOUWUFDARENZHENG/YOUDEHUAXUTIGONGFDAHAOMA)。

  5. Calibration Report of Power Meter

  GUANGGONGLVJINIANDUJILIANGJIANDINGHEGEZHENGJIBAOGAO。

亚博全站   6. Quality Control System

  ZHILIANGKONGZHIWENJIAN:ZHUYAOBAOHANNEIBUZHILIANGKONGZHILIUCHENGBIAOTU、JIANYANGUICHENG、ZHIKONGGUIFAN/RUSHEJIXIUGAIFANGMIANDEGUANKONG;SHENGCHANXIANCHOUYANGBIAO、LAILIAOJIANCEDAN、CHENGPINJIANCEDAN、NEIBUJIANYANBAOGAODENG(HANBIAOGEDEYANGBEN)。

  7. US Agent / Importer

亚博全站   MEIGUODAILIRENJIMEIGUOJINKOUSHANGXINXI:BAOKUOLIANXIRENWANZHENGXINGMING、DIANHUA/CHUANZHEN/DIANYOU、MEIGUOXIANGXIDIZHI/YOUZHENGBIANMA、GONGSIMINGCHENG;YIJIU.S. AgentWEITUODAILISHOUQUANXIEYI。

亚博全站   SHENZHENSHIYIBOJIANCEZUOJIANCERENZHENG12NIAN,SHIZHUANYEQUANWEIDEDISANFANGJIANCERENZHENGJIGOU,LEJIEGENGDUOFDARENZHENGZIXUNKESUISHILIANXIWOMEN:13543272595


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