Ensure FDA
Compliance with a
Reliable US Agent
Medical device companies, based outside the US must appoint a US Agent to register with FDA. Without one, your shipments risk delays, detentions, or refusal.
2,000+ Medical Device Manufacturers Trust Registrar Corp
What Is an FDA US Agent?
A US Agent is a legally required representative for foreign medical device manufacturers and exporters selling products in the US The agent:
- Acts as the official contact for FDA on behalf of the foreign facility
- Handles regulatory communications such as inspections, warning letters, and compliance requests
- Assists with emergency situations where FDA must reach the company immediately
- Ensures that registration and compliance updates are completed on time
Why Registrar Corp?
Registrar Corp’s regulatory team is available 24/7 to handle urgent FDA communications, helping you avoid delays and compliance risks. With expert support in device registration, UDI, and detentions, we serve as more than a point of contact—we’re your regulatory partner in the US
Who Needs an FDA US Agent?
All foreign establishments involved in the manufacture, preparation, propagation, compounding, or processing of medical devices intended for sale in the United States must appoint a US Agent when registering with FDA. This includes:
Medical device manufacturers
Contract manufacturers
Specification developers
Repackers and relabelers
Foreign exporters shipping to the US
With a dedicated account coordinator assigned to every client, Registrar Corp provides personalized guidance throughout the registration process—ensuring you remain in good standing with FDA and ready for regulatory changes.
Key Responsibilities of a US Agent
The US Agent receives official FDA communications on behalf of the foreign medical device company. This includes inspection notifications, regulatory inquiries, and enforcement actions such as warning letters or import alerts.
Registrar Corp Advantage
We’re available 24/7 to respond to urgent communications and ensure you never miss an important notice—protecting your compliance and business continuity.
Emergency Contact for FDA
In case of public health concerns, product recalls, or safety issues, the US Agent must be available 24/7 to respond to FDA inquiries. Failure to provide timely responses may lead to shipment holds or compliance penalties.
Registrar Corp Advantage
You can rely on us in high-stakes situations. Our experienced team provides immediate regulatory support and guides you through recalls or enforcement actions.
Assistance With FDA Registration and Compliance
The US Agent helps foreign companies complete FDA medical device registration and ensures all required information is submitted correctly. Assists with annual registration renewals to prevent disruptions in product distribution.
Registrar Corp Advantage
We handle annual FDA registration and renewals, help you stay compliant year after year, and support updates to device listings as regulations evolve.
Import Support and Regulatory Guidance
The US Agent works with FDA and US Customs and Border Protection (CBP) to help resolve potential import issues. If a product is detained or refused entry, the agent assists in addressing compliance concerns.
Registrar Corp Advantage
Our regulatory specialists assist with detentions and import holds, helping keep your products moving and your supply chain intact.
What Happens If You Don’t Appoint a US Agent?
Failure to designate a US Agent can lead to serious compliance issues, including:
Registration delays
Your medical device facility cannot be registered without a US Agent
Product holds and import refusals
Devices may be detained at US ports if no U.S. Agent is listed
FDA communication failures
Missing critical FDA notices can result in non-compliance
Potential penalties and enforcement actions
Companies that fail to maintain compliance risk warning letters or product recalls
Don’t Risk Shipment Delays or
Compliance Issues
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