US Agent service
U.S. Agent Service
For medical device manufacturers outside the U.S., designating a U.S. Agent is a key requirement for FDA compliance. This role serves as your official liaison with the FDA, supporting everything from product registration to inspection coordination and incident communication.
With Sobel as your full-service U.S. Agent, international companies get the support they need to enter and thrive in the U.S. medical device market. Our team can act as your authorized representative, so you gain both regulatory clarity and peace of mind.
How We Support Your Company as FDA U.S. Agent
A U.S. Agent is a person or entity located in the United States who is designated by a foreign establishment to act as its official representative for FDA-related communications.
This role is mandatory for non-U.S. manufacturers and essential for smooth interaction with FDA authorities.
As your FDA registration agent, Sobel provides:
Official representation for non-U.S. medical device manufacturers
Ongoing communication with the FDA regarding your device and establishment
Support in responding to FDA inquiries and managing regulatory correspondence
Coordination of FDA inspections and communication with inspection teams
Management of establishment registration and product listing updates
Fast action in the event of a vigilance or incident report involving your device
Optional expansion into clinical, regulatory, and biological evaluation support as needed
Why do you need this service?
If your company is located outside the U.S., appointing a FDA US agent is mandatory for product registration, market entry, and maintaining regulatory standing.
We manage all official correspondence with the FDA, helping you respond quickly to requests, avoid miscommunication, and stay on top of your regulatory obligations.
From coordinating inspections to assisting in post-market incidents, our team is prepared to act swiftly—minimizing delays and maintaining compliance.
Having a qualified U.S. Agent means your medical device is represented with professionalism and precision in the U.S. market. With the right partner, you gain more than compliance—you gain strategic support for long-term success.
Let Sobel be your official point of contact for U.S. Regulatory Success!
Looking for a U.S. Agent?
As your FDA registration agent, we handle the regulatory burden so you don’t have to. Whether you’re registering a new product or expanding your U.S. operations, Sobel is here to support you with speed, accuracy, and expertise.
Facilitate smooth U.S. market entry with Sobel as your trusted U.S. Agent. Contact us today to simplify FDA compliance and regulatory communications.
