U.S. Agent
Initial Importer and FDA Representation
for medical devices and IVDs
The reference partner for the US market
U.S. Agent
Foreign medical device manufacturers marketing products in the United States must appoint a U.S. Agent as per 21 CFR Part 807.40, and in many cases an Initial Importer for logistics and compliance purposes.
ALTRION acts as your regulatory representative in the U.S., ensuring direct communication with the FDA and managing product importation oversight.
Our Services
- U.S. Agent appointment and FDA registration (FEI & Owner/Operator numbers)
- Support for Establishment Registration and Device Listing
- Review and update of 510(k) or De Novo submissions
- Coordination with customs and importation partners
- Optional Initial Importer designation for distribution purposes
- Assistance during FDA inspections or communications
Why Choose ALTRION
- Recognized presence and partnerships in the U.S. regulatory ecosystem
- Integrated support with FDA 510(k) submission services
- Experience handling device listings, recalls, and compliance audits
Deliverables
- U.S. Agent Appointment Letter (FDA Form 3674 equivalent)
- Confirmation of Establishment Registration and Device Listing
- Annual FDA registration maintenance and inspection readiness package
Bring your medical devices to the United States
Fill out the form with your request.
We will contact you as soon as possible.
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