public 眼镜注意事项

info

view_module眼镜注意事项

Dear All :

FDA對眼鏡的要求, 這是7/19才發布的警示. 

進口到美國的眼鏡和太陽鏡都必須符合21 CFR 801.410,“使用耐衝擊眼鏡和太陽鏡的鏡片”證書,
符合21 CFR 801.410(七)必須陪顯示鏡頭製造商的眼鏡和太陽鏡的每個條目進行測試或使用(D)

段所述的撞擊測試(2)21 CFR 801.410或任何相等的鏡頭優越的測試。*** 據報導,來自國外廠商的證書未必有效。一個美國經銷商的測試結果表明40-70%破損顯著不同製造商的證書。 

由於明顯證書違規SAN的兒童太陽鏡收集樣本。製造商的證書表明,在測試過程中沒有鏡片的爆發。然而,樣品WEAC測試發現,幾乎每一個鏡頭完全打破了。 

***最近的SAN-DO的成人處方鏡片收集樣品。樣品WEAC測試發現,38%的鏡頭完全打破了。***

http://www.accessdata.fda.gov/cms_ia/importalert_237.html

801.410文件 - 耐衝擊鏡片的眼鏡和太陽鏡的使用。 有說明如何測試 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.410

非處方太陽鏡的指導性文件
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073951.htm


 

Can you please send me the copy of the Impact Test (drop test) that includes the FDA registration number? I am working with my contact in China on getting everything coordinated to be shipped out.

 

Thank you J

 


 2015-07-16_142008.jpg2015-07-16_142008.jpg



申请在线申请ASI

参考价: $0

美国ASI协会方案
+¥5500
+¥4500
+¥40000
+¥1500
+¥4000

exit_to_app培训(60)
exit_to_app西联汇款(11)
exit_to_app外贸工具(15)
exit_to_app低成本创业(18)
exit_to_app关税(13)
exit_to_app产品风险(24)
exit_to_appPaypal(21)
exit_to_app邮件(13)
exit_to_app信用卡(7)
exit_to_appASI手册(27)
exit_to_app外贸SEO(9)
exit_to_appphotoshop技巧(6)
exit_to_app销售技巧(2)
exit_to_app供应商黑白名单(5)
exit_to_app海运费策略(26)
exit_to_app快递策略(38)
exit_to_appDDP(4)
exit_to_appDC(2)
exit_to_appGmail(13)
exit_to_app产品培训(4)
exit_to_app外贸询盘(5)
exit_to_appASI(87)
exit_to_app卖法研究(4)
exit_to_app关税(13)
exit_to_app业务员故事(4)
exit_to_app离岸公司(10)
exit_to_app包装(7)
exit_to_app谈判技巧(14)
exit_to_app验货(5)
exit_to_appsage(7)
exit_to_app看老外学英语(12)
exit_to_app开发客户渠道(5)
exit_to_appKMH提成系统(3)
exit_to_app品牌授权(2)
exit_to_app潘通色卡(4)
exit_to_app印刷(11)
exit_to_app矢量图(10)
exit_to_app收款(22)
exit_to_app程序代码(23)
exit_to_app美国ASI代理(21)