The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the
如果你没有向美国 FDA 注册
Registrar Corp's team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
帮助您确定是否符合产品注册豁免条件，如果没有，我们将为您向FDA提交注册申请，并在需要的时候帮助修改、更新和取消注册，不收取额外费用。
帮助确定FDA医疗器具用户费用 是否为注册要求，如果不是，我们将按美国FDA规定帮助您准备和提交付款。
Registrar Corp签发的注册证书可以确保您在FDA的有效注册，同时可避免因意外遗失重要信息。
If you are already registered with the U.S. FDA
选择下述的一个选项:
选项1 ： 定购注册证书
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with the registration requirement of the U.S. Food, Drug and Cosmetic Act.
Registrar Corp签发的证书，可以向您的客户证明您的医疗器具产品在FDA注册正确并有效。
随运送货物附带由Registrar Corp签发的证书，可以避免错误和延迟。
一旦定购了证书，您会定期收到简化表格以便让我们快速更新您在FDA的注册信息。 这样可以确保您的FDA注册信息实时正确无误，同时可避免因意外遗失重要信息。
选项2 ： 如果你的注册信息已经遗失
Companies often misplace their registration information. If you do not have your U.S. FDA Medical Device FURLS information, you will not be able to update your Medical Device registration information as required by U.S. FDA. For assistance recovering your U.S. FDA FURLS and registration information, click below.
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Option 4: Change
It is prudent to separate commercial relationships from the responsibilities of your Official Correspondent for U.S. FDA communications because of potential conflicts of interests. Correct this by designating Registrar Corp as your Official Correspondent for U.S. FDA Communications and receive your Certificate of Registration issued by Registrar Corp.
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