US AGENT

US AGENT and Official Correspondent

Foreign manufactures are required to appoint a US Agent during the Establishment Registration. A US Agent must either reside or maintain a place of business in the United States. The US Agent cannot use a Post Office Box as an address or use a answering service. The US Agent must be available to answer the phone or have an employee answering the phone during business hours. TechLink International serves as the US Agent for importers of FDA regulated products. From submissions assistance to Facility registrations, to detained products, our team of qualified experts work with regulatory authorities to solve problems, ensure compliance and file required documentation accurately and in a timely manner.

Responsibilities of the US Agent

• Assisting the FDA in communications with the foreign establishment,
• Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
• Assisting the FDA in scheduling inspections of the foreign establishment, and
• If the FDA is unable to contact the foreign establishment directly or expeditiously, the FDA may provide information or documents to the U.S. Agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Contact Us

Additional Information on the US Agent can be found on the link below:
https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents