昆山森维检测技术服务有限公司
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◆昆山森维检测技术服务有限公司◆
电话:+86-0512-57168309
传真:+86-0512-57168305
微信:森维业务经理:18994465687
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地址:江苏省昆山巿中华园路850号410室四季商城 215000

     美国FDA(510K)食药品认证
美国FDA辐射发射电子装置法规
发布人: 发布时间:2017-5-1 点击:802次
美国FDA辐射发射电子装置法规

在向美国提供进口产品之前,每个电子产品制造商都必须指定美国代理进行流程服务。此外,一些制造商,装配商或进口商可能需要向FDA提供额外的产品报告。
森维可以作为您的美国代理进行流程服务,并在需要时协助提交产品报告。

美国FDA辐射发射电子设备要求设备示例
辐射发射装置报告证书
要获得美国FDA辐射发射电子设备法规的帮助,请询问森维。

辐射发射电子器件产品和卷标审查

森维帮助公司确定其产品是否可能被美国FDA视为辐射发射电子设备。对于可能被认为是辐射发射电子设备的产品,森维提供有关美国FDA卷标要求和性能标准以及其他美国FDA规定的指导。要了解美国FDA辐射发射电子设备法规如何适用于您的产品,请询问森维。

U.S. FDA Radiation-Emitting Electronic Device Regulations

Every manufacturer of electronic products, prior to offering such product for importation into the United States, must designate a U.S. Agent for service of processes. In addition, some manufacturers, assemblers, or importers may be required to provide additional Product Reports to FDA.

Sanwei can serve as your U.S. Agent for service of process and assist with submission of Product Reports, if required.

U.S. FDA Radiation-Emitting Electronic Device Requirements   Device Examples
 Radiation-Emitting Device Certificate of Reporting 
For assistance with U.S. FDA Radiation-Emitting Electronic Device regulations.

Radiation-Emitting Electronic Device Product and Labeling Review
Registrar Corp helps companies determine whether their products may be considered a Radiation-Emitting Electronic Device by the U.S. FDA. For products that are likely considered a Radiation-Emitting Electronic Device, Registrar Corp provides guidance regarding applicable U.S. FDA labeling requirements and performance standards, as well as other U.S. FDA regulations. To learn how U.S. FDA Radiation-Emitting Electronic Device regulations may apply to your products.

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