United States Agent Service
Enter the U.S. market with a proven FDA expert
100+ FDA listings with 25+ years of experience.
Enter the U.S. market with confidence. MEDAGENT-supported devices have recorded a lower rate of reported nonconformities during FDA inspections than the global average.
With a 30 minute meeting with us, discover your road to the US, the costs involved, and a timeline. Letting you focus on what you do best while letting us handle the paperwork.
Everything you need for the U.S. market, all in one place
U.S. Agent Representation
FDA Registration & Renewal
Official Correspondent
Device Initial Importer
QMSR Audit Support
eMDR & Regulatory Support
One partner for your entire U.S. market journey. From appointing your U.S. Agent and registering your establishment to listing your devices, managing FDA communication and supporting inspections, MEDAGENT brings every essential service together through one experienced team and one reliable point of contact.
Support that continues after market entry
Entering the U.S. market is only the beginning. MEDAGENT provides ongoing regulatory support to help you stay prepared, informed and compliant as requirements change. From annual FDA registration and device-listing updates to FDA correspondence, eMDR support and inspection preparation, our experts remain your reliable point of contact throughout the lifecycle of your medical devices.
- Annual registration and renewal support
- FDA correspondence and regulatory updates
- Device-listing and company-detail changes
- eMDR and inspection support
- Coordinate FDA communications by responding to agency inquiries and regulatory requests.
- Direct access to experienced regulatory specialists
What MEDAGENT handles
Scared of U.S. market entry requirements? Don’t be. From FDA communications and establishment registration to inspection preparation and electronic Medical Device Reporting (eMDR), we provides practical support tailored to your needs. Choose from six service levels, covering everything from basic U.S. Agent representation to extended regulatory assistance. Here’s what we do:
- Provide U.S. Agent service tailored to your regulatory needs, from standard representation to extended regulatory assistance.
Act as your designated U.S. Agent and serve as the official point of contact between your foreign establishment and the FDA
Coordinate FDA communications by responding to agency inquiries and regulatory requests.
Assess the appropriate FDA regulatory pathway by reviewing your device’s classification and intended use to help determine whether a 510(k), De Novo request, Premarket Approval (PMA), or another pathway applies.
Prepare and review regulatory documentation for FDA submissions, including 510(k), De Novo, and PMA applications, to help address applicable content and documentation requirements.
Support FDA establishment registration and device listing through authorized access to registration systems, including sub-accounts.
Support FDA inspection readiness and coordination through preparation, documentation reviews, scheduling assistance, and on-site inspection support where agreed.
Assist with electronic Medical Device Reporting (eMDR) by preparing and submitting Medical Device Reports (MDRs) on your behalf, where agreed.
4 Easy Steps to start your successful launch in the United States!
Explore OUR Difference
Why manufacturers choose MEDAGENT
You tell us! Since 2004, we’ve supported international manufacturers through 165+ FDA inspections, 130+ establishment registrations annually, and 200+ device listings each year. We put this experience to work for you, from preparing regulatory submissions and coordinating FDA communications to supporting inspection readiness and ongoing regulatory obligations.
Entering the U.S. market shouldn’t mean facing FDA requirements on your own. While you remain responsible for your devices’ regulatory compliance, quality, and safety, we can take on additional operational tasks, including FDA establishment registration, device listing, submission preparation, and regulatory communication. This gives you a single partner for both U.S. Agent representation and broader FDA regulatory support.
We know that a well-planned regulatory strategy is essential for entering and operating in the U.S. medical device market. That’s why we focus on clear responsibilities, efficient processes, and close collaboration to help you address regulatory challenges before they become obstacles.
Planning your U.S. market entry? Let’s discuss your regulatory requirements and define the next steps together.
Your Guide to the U.S. Medical Device Market
Understand FDA Requirements and Plan your Next Steps.
Entering the U.S. medical device market starts with understanding the regulatory requirements. From device classification and FDA submission pathways to establishment registration and device listing, knowing what applies to your product can make all the difference.
Our free guide provides an introduction to the key FDA requirements for international medical device manufacturers. Learn about regulatory pathways such as 510(k), De Novo, and PMA, understand the role of a U.S. Agent, and discover what to consider when preparing your market entry.
Get the regulatory overview you need to plan your next steps with confidence.
Stay Informed & Ahead on Regulatory Changes
We publish monthly newsletters that summarize the latest developments, updates and key changes in medical device regulations worldwide on our LinkedIn Newsletter.
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