US Agent and Correspondent

Your Regulatory Presence in the United States

Entering and maintaining access to the U.S. market requires more than registration. It requires reliable, real-time regulatory communication with the U.S. Food and Drug Administration. For foreign manufacturers, this is not optional. A designated U.S. Agent is required for FDA registration and serves as the primary communication link between your company and the FDA.

Medical Devices and Pharma (MDP) provides more than a name on a form. We serve as your U.S.-based regulatory presence, ensuring that FDA communications are received, understood, and acted upon without delay.

Why This Matters

Failure to maintain effective communication with the FDA can result in several issues, to include delayed or denied product registration, missed or misinterpreted FDA inquiries, import holds or refusals at U.S. ports of entry, inspection delays or escalations, and increased regulatory risk exposure.

And in time-sensitive situations like recalls, inspections, or compliance actions, your U.S. Agent becomes critical infrastructure.

What a U.S. Agent Actually Does

Many providers position this role as administrative. It is not.

Your U.S. Agent is responsible for receiving FDA communications on your behalf, responding to time-sensitive inquiries, coordinating inspection-related communication, supporting resolution of import or compliance issues, and ensuring communication continuity across time zones.

At MDP, this role is performed with regulatory expertise, not just availability.

U.S. Agent vs Official Correspondent

Understanding the distinction is essential. A U.S. Agent (Required for Foreign Manufacturers) must be in the United States and serves as FDA liaison for communications to support inspections and compliance and is an emergency contact for your company.

Official Correspondent

An official correspondent manages FDA registration and listing (FURLS), maintains establishment records, and may be located inside or outside the U.S.

MDP can support both roles, ensuring consistency across your regulatory interface.

MDP Services: Beyond the Minimum Requirement

Core U.S. Agent Functions

The core functions of a U.S. Agent are FDA communication intake and response coordination, inspection notification and scheduling support, import-related communication assistance, and time-sensitive issue escalation.

Enhanced Regulatory Communication Support

This is where MDP differentiates from other companies that offer services as a U.S. agent. We provide interpretation of FDA communications in regulatory context, regulatory alignment with QMSR and ISO 13485 expectations, guidance on appropriate internal response actions, and support during recalls, field actions, or compliance events.

U.S. Market Entry Support

For companies entering the U.S. market we provide FDA registration and listing guidance, an overview of U.S. regulatory expectations, a communication readiness assessment, and integration with your quality management system.

Why Choose MDP

Our Regulatory Expertise

MDP is led by professionals with deep experience in FDA-regulated medical devices, quality systems and compliance, and life-sustaining and high-risk technologies.

We Are Independent and Objective

Unlike distributors or commercial partners, MDP operates as an independent regulatory representative, a conflict-free communication channel, and a trusted interface with U.S. regulators.

Communication You Can Rely On

We offer a U.S.-based presence with rapid response capability and clear, accurate, and defensible communication. MDP can work with companies outside the United States, including manufacturers in China, Mexico, Europe, and emerging global markets. We serve as the bridge between your organization and U.S. regulatory expectations, ensuring that nothing is lost in translation – technically or operationally.

Strategic Value

A qualified U.S. Agent is not just a regulatory requirement. It is a risk management function, compliance safeguard, and an operational communication system. With MDP, you gain a regulatory partner, not just a point of contact.

Integrated Regulatory Support

Our clients can extend U.S. Agent services into QMSR transition support, internal audit and gap assessments, CAPA and compliance remediation, and recall and field action communication. Ask about bundled service options.

Get Started

If your organization requires a U.S. Agent for FDA registration, an Official Correspondent for listing management, or a stronger, more reliable U.S. regulatory communication presence, we invite you to connect.