Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S....

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug imported into the United States must identify a United States agent (U.S....

2018年2月8日 · Foreign establishments who import or offer for import into the United States must identify an FDA U.S. Agent during the registration process. The FDA U.S. Agent must be physically located in the United States and will serve as the primary and/or default point of contact between FDA and the firm.

FDA contacts US Agents for new labeler code assignments, registration and listing deficiencies, amongst other reasons •If we have reason to believe US Agent information on Labeler Code SPL or

2025年1月10日 · What does an FDA US agent do? Every medical device company outside the USA that distributes devices in the USA must have an FDA US agent. This includes manufacturers, contract manufacturers, and specifications developers outside the USA. The US agent assists the FDA in communication with the device company.

The United States agent is responsible for: ( 1 ) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications; ( 2 ) Responding to questions concerning those drugs that are …

作为一家在与欧美药监机构沟通方面拥有丰富经验的医疗器械产品注册咨询公司，Abmed在与众多企业的合作过程中，发现客户在FDA的申报和产品开发过程中，对涉及美国代理（US Agent）的服务必要性及其所带来的价值有着…

美国食品药品监督管理局（FDA）规定，美国以外的医疗器械、食品、酒类、药品等工厂在美国上市之前必须进行注册，同时必须指定一位美国代理人（U.S. Agent）。

FDA美国代理人us agent服务包括： 1） 我们能及时地跟踪和通报美国境内和您的产品相关的法律法规最新的发展情况。 2） 我们能协助您处理产品的事故报告、通告、召回。

2025年2月4日 · A US Agent for FDA registration is an individual or entity located in the United States that acts on behalf of a foreign company to ensure it complies with FDA regulations. The US Agent’s primary responsibilities include managing communication with the FDA, assisting with FDA registrations, and handling any necessary follow-ups with the agency.