US FDA Agent For Medical Device

For foreign manufacturers looking to market their medical devices, pharmaceuticals, or food products in the United States, appointing a US FDA Agent is a critical regulatory requirement. We offer specialized US FDA Agent services to ensure seamless communication with the FDA and compliance with all regulatory obligations.

A US FDA Agent acts as a liaison between foreign manufacturers and the FDA. This agent is responsible for facilitating communication, responding to FDA inquiries, assisting with product registrations, and ensuring timely submission of regulatory documents. Having a reliable FDA Agent is essential for maintaining compliance and addressing any regulatory issues that may arise.

Cert3global is a reputed and experienced FDA Agent for assisting medical device manufacturers (also food, drugs, nutraceuticals, toys, and cosmetic exporters). Each Foreign manufacturer must appoint only one US Agent & can also (not required) appoint them as its official correspondent.

Responsibilities of US FDA Agent!

  • Serve as a liaison (bridge) between the FDA and foreign manufacturers.
  • Be aware of the latest happenings from the FDA.
  • Facilitate facility registration and account maintenance
  • Communicate with the FDA as needed
  • Provide label review services and GMP[Good Manufacturing Practice]  guidance (additional fees may apply)
  • Assist the FDA with scheduling foreign facility inspections
  • Conduct annual registration updates
  • Update importer information for drugs and medical devices
  • Allow additional listings throughout the service year
  • Perform initial Registration and listing
  • Verify DUNS [Data Universal Numbering System] numbers and addresses
  • safeguard login information, and Issue Registration Certificates.

Additional Information