US Agent for Medical Devices and IVD Companies
Overview
Appoint MDRA as your U.S. FDA Agent and learn what we do as your liaison with the FDA.
U.S. FDA Agent requirement
If your company has no U.S. presence, FDA regulations require you to designate a U.S. FDA Agent who is a U.S. resident or maintains a physical U.S. business address. The U.S. Agent acts as the primary local contact between your firm and the FDA for medical devices and IVDs marketed or imported into the United States.
U.S. Agent responsibilities
A U.S. Agent’s core duties include:
- Assisting the FDA in communications with your company.
- Responding to FDA inquiries about your imported products.
- Assisting the FDA in scheduling inspections of your facilities.
Because the FDA may deliver information or documents to the U.S. Agent as if they were delivered to your company, select a reliable, professional regulatory representative.
Why appoint MDRA as your U.S. FDA Agent?
- Specialized regulatory expertise for medical devices and IVDs worldwide.
- A dedicated team that manages representation tasks professionally, confidentially, and promptly.
- Independent, third‑party representation focused on your interests—not sales.
- Single-source in-country representation available in 20+ markets, simplifying cross-market vigilance and recall coordination.
- Employee-staffed offices in the U.S., UK, EU and other regions for direct local support.
Appointing MDRA is an efficient way to ensure professional U.S. representation and reliable FDA communication.
Common questions
What is an Official Correspondent?
The Official Correspondent is the contact listed in establishment registration whom the FDA will attempt to reach first. This role can be someone outside the U.S., unlike the U.S. Agent. Many companies choose MDRA as Official Correspondent to ensure FDA inquiries are handled correctly.
Why use a regulatory firm rather than a distributor?
Distributors focus on sales and may lack the regulatory knowledge or impartiality needed if the FDA contacts them about an incident. A professional regulatory firm provides consistent, expert representation regardless of distributor changes and prioritizes your regulatory and legal interests.
Egypt Registration Holder (ERH)
UK Responsible Person (UKRP)
