電動牙刷類產品出口美國做FDA認證詳解，FDA認證容易過嗎
經過郵件與FDA網站聯系后學習得到一些相關信息。
· FDA重要提醒聲明，原文參考此鏈接。
· FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
如果您的產品需要認證，歡迎聯系深圳安博檢測股份有限公司
電動牙刷法規(guī)的一般要求：
使用FDA法規(guī)標準：
|
Regulation Number |
872.6865 |
提交注冊型：
|
Submission Type |
510(K) Exempt |
電動牙刷屬于**器械Class I，Class I devices are subject to general controls.
|
Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
|
If a manufacturer"s device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
根據這段話，電動牙刷使用的標準為：21 CFR parts 872.6865，在豁免條款里面，我們只需要做注冊就好，有鏈接參考。
值得注意的是 FDA注冊需要美國代理商，4884美金。FDA注冊是沒有證書的，產品通過在FDA進行注冊，將取得注冊號碼，FDA會給申請人一份回函（有FDA行政長官的簽字），但不存在FDA證書一說。FDA是一個執(zhí)法機構，而不是服務機構，FDA既沒有面向公眾的服務性認證機構與實驗室，也沒有所謂的“實驗室”。
安博檢測-梁蓮花
我是深圳安博檢測的蓮花，公司主營業(yè)務有:
中國：CCC, SRRC, 入網許可，CQC，質檢報告，NCC，BSMI。
歐盟：CE/CE-RED，EN71, ROHS, REACH, GS, WEEE，LFGB等
北美：FCC-SDOC，FCC-ID，IC，IC-ID，FDA，UL/cUL, ETL/cETL，加州65等。
日本：PSE，VCCI，TELEC，JATE。韓國：KC,KCC,
澳洲：RCM，SAA,
中東非洲：沙特SASO，尼日利亞的SONCAP，肯尼亞的PVOC，南非LOA等等
電池：UN38.8全套，CB，電池指令，GB31241，GB18287，CQC1134.等
燈具能效：LM-79，TM-21，DLC，CEC，DOE，能源之星，ERP，IEC62717，IEC62722，IES，積分球（能效有美國NVLAP和中國CNAS授權），
可靠性測試：MTBF平均無故障時間測試（壽命測試）跌落，撞擊，振動/震動，摩擦，高/低溫，鹽霧，IP防塵防水等級測試,IK碰撞等級測試。
測試費用一般是多少，周期需要多久，需要提供的資料，以及需要的樣品數量是多少，歡迎來電咨詢：壹叁五叁柒捌貳捌貳叁玖（薇信同號） 梁蓮花 Q 叁零五捌零柒肆貳壹貳
Company深圳安博檢測股份有限公司
Add：深圳市寶安區(qū)西鄉(xiāng)街道后瑞第三工業(yè)區(qū)A棟4樓
安博檢測提供專業(yè)的技術支持，良好的認證服務，希望我們的合作共贏！
|
