FDA Registration Requirements for Foreign Medical Device Manufacturers

Who Must Register: Foreign Establishments Exporting to the U.S.

Under 21 CFR Part 807, any establishment outside the United States that manufactures, processes, or packages a finished medical device intended for commercial distribution in the U.S. market is required to register with FDA. This obligation applies regardless of the country of origin — whether the manufacturer is based in China, Germany, South Korea, Israel, or anywhere else in the world. If the device ends up sold or distributed to U.S. customers, the foreign establishment that made it must be registered.

The statute covers more than just finished-device manufacturers. Foreign contract manufacturers, specification developers, and sterilization facilities that are part of the supply chain for a U.S.-marketed device may also have registration obligations depending on their role. When in doubt about whether a specific facility must register, FDA's guidance on device establishment registration — and a conversation with a U.S. regulatory consultant — is the right starting point.

One narrow exemption exists for foreign establishments that import components or devices solely for incorporation into a product that is then exported from the United States without ever being sold domestically. This "import for export" exception is specific and fact-dependent; it does not apply to devices that enter U.S. commerce in any form.

What Is a U.S. Agent — and Why the Requirement Exists

Every foreign establishment required to register with FDA must also designate a U.S. Agent: a person or business entity that resides in or maintains a place of business in the United States and serves as FDA's primary point of contact for that foreign manufacturer. This requirement exists because FDA's enforcement and communication mechanisms are designed around U.S.-reachable entities. When FDA needs to communicate with a foreign facility — about an inspection, an import alert, a product defect notice, or a warning letter — the U.S. Agent is the designated recipient.

The U.S. Agent is not a passive mailbox. FDA regulations require that the U.S. Agent be available during U.S. business hours to receive FDA inquiries and transmit them to the foreign establishment. An unreachable or unresponsive U.S. Agent is itself a compliance problem that can lead to regulatory action against the foreign manufacturer.

The U.S. Agent must be a U.S.-based entity. Foreign companies cannot designate themselves, a foreign subsidiary, or any person residing outside the U.S. The agent can be an individual, a company, or a regulatory consulting firm that has agreed to serve in this role for the manufacturer.

What a U.S. Agent Is Responsible For

The U.S. Agent's responsibilities under FDA regulations are specific. They include:

• Receiving and forwarding official FDA communications — including import alerts, warning letters, 483 observations, and requests for information — to the foreign establishment
• Responding to FDA inquiries on behalf of the foreign establishment when the establishment has authorized the agent to do so
• Remaining reachable by FDA at a U.S. phone number and address during standard U.S. business hours
• Maintaining accurate contact information in FDA's FURLS system so FDA can reach the agent without delay
• Promptly notifying the foreign establishment when FDA contact occurs

What a U.S. Agent is not: a legal representative in the full sense of an attorney, an importer of record, a third-party logistics provider, or a domestic distributor. Those roles exist separately and may overlap in some arrangements, but they are distinct from the FDA-designated U.S. Agent designation. A U.S. Agent who is also a distributor or regulatory consultant may provide additional services, but the U.S. Agent function is a specific, regulated role with specific obligations.

How to Register a Foreign Establishment in FURLS

Foreign establishment registration is completed through FDA's Unified Registration and Listing System (FURLS), the same online system domestic establishments use. The process for a foreign establishment has a few additional steps compared to domestic registration, centered on the U.S. Agent designation and country-of-establishment information.

At a high level, the registration process for a foreign manufacturer works as follows:

• Create a FURLS account. The foreign manufacturer (or a regulatory representative acting on their behalf) creates an FDA Industry Systems account, which provides access to FURLS. First-time users will need to complete an identity-verification step before the account is active.
• Complete establishment information. The manufacturer enters the establishment name, physical address, country of establishment, and contact information. FDA requires the complete physical address — P.O. boxes are not accepted for establishment registration.
• Designate the U.S. Agent. The manufacturer enters the U.S. Agent's name, address, phone number, and email address in the FURLS registration. The U.S. Agent then receives a notification from FDA and must confirm the designation through their own FDA Industry Systems account. Both parties must complete this step for the designation to be finalized.
• List devices. After establishing the registration, the manufacturer must list the devices manufactured at that facility, including the applicable product code, device name, and regulatory class. Device listing and establishment registration are separate but linked obligations.
• Pay the user fee. Foreign establishments are subject to the same annual establishment registration user fee as domestic establishments. The fee amount is set by FDA each fiscal year and changes annually. Current fee information is available directly from FDA's user fee program page at fda.gov. The fee must be paid before registration is complete.

How to Designate a U.S. Agent in FURLS

The U.S. Agent designation in FURLS is a two-step process that requires action from both the foreign manufacturer and the prospective U.S. Agent. The manufacturer initiates the designation by entering the agent's information during the FURLS registration. FDA then sends the named U.S. Agent an email notification with a confirmation link. The U.S. Agent must log into their own FDA Industry Systems account and formally accept the designation.

Until the U.S. Agent has confirmed the designation, the registration is not complete. This is a common source of delay for foreign manufacturers working with a new agent: the agent must already have an active FDA Industry Systems account (or create one), and they must respond to the confirmation request promptly. Choosing a U.S. Agent who is familiar with the FURLS designation process and has an existing FDA account reduces friction considerably.

The U.S. Agent's information in FURLS — name, address, phone, and email — must remain current at all times. If the agent's contact information changes, it must be updated in FURLS immediately, not at the next annual renewal window.

Annual Renewal Obligations

FDA establishment registration is not a one-time event. Foreign establishments, like domestic ones, must renew their registration annually. The renewal window is October 1 through December 31 of each year. Establishments that fail to renew within this window are considered unregistered for the following calendar year — meaning their devices may be subject to import detention at the U.S. border until the registration is brought current.

Annual renewal in FURLS involves confirming or updating establishment and device listing information, reviewing and updating U.S. Agent information if needed, and paying the annual FDA user fee for the new fiscal year. The FDA user fee for registration is assessed per establishment, not per device, and the amount changes each year based on FDA's budget calculations under MDUFA.

Foreign manufacturers with multiple U.S.-marketed device lines but a single registered establishment pay one establishment fee, though each device family must be listed. Manufacturers with multiple distinct facilities — a factory in one city and a sterilization facility in another, for example — may need to register each facility separately.

Consequences of Failing to Register or Renew

The consequences of operating without an active FDA registration are serious and concrete. The primary enforcement mechanism for unregistered foreign establishments is import detention: U.S. Customs and Border Protection, acting on FDA's import alert system, can detain shipments from unregistered foreign facilities at the port of entry without physical examination of the products. Detained shipments remain in customs hold at the importer's expense while the situation is resolved.

An import alert designation — specifically Import Alert 89-08, which covers unregistered foreign establishments — is a public record and can damage commercial relationships with U.S. distributors and customers who discover the compliance gap. Resolving an import alert requires correcting the underlying registration issue and, in some cases, actively requesting that FDA remove the establishment from the alert list after the deficiency is addressed.

Beyond import detention, failure to register is a prohibited act under Section 301(p) of the Federal Food, Drug, and Cosmetic Act. FDA can issue warning letters and pursue injunctive action against foreign establishments that fail to register, though import detention is typically the first and most immediate consequence for foreign manufacturers.

Unique Requirements for Foreign Registrations: Official Correspondent and Country of Establishment

Foreign establishment registrations in FURLS require two pieces of information that domestic registrations do not: the country of establishment and the designation of an Official Correspondent. The country of establishment is straightforward — it identifies the nation in which the manufacturing facility is physically located.

The Official Correspondent is the designated point of contact within the establishment for regulatory communications from FDA. This person receives copies of communications FDA sends to the U.S. Agent, providing a direct line of communication within the foreign facility. The Official Correspondent must be a person associated with the establishment itself — not the U.S. Agent — and their contact information must be current in FURLS.

Together, the U.S. Agent and the Official Correspondent form the communication chain that FDA relies on to reach foreign establishments. Both roles must be actively maintained, with current contact information, for a foreign registration to function as intended.

Changing Your U.S. Agent

Foreign manufacturers sometimes need to change their U.S. Agent — because the current agent is no longer providing the service, because the manufacturer is working with a new regulatory consulting firm, or because the existing agent's responsiveness has been inadequate. The process for changing a U.S. Agent mirrors the initial designation: the manufacturer updates the FURLS registration with the new agent's information, and the new agent must confirm the designation through their FDA account.

Timing matters when making a U.S. Agent change. The new designation does not take effect until the new agent has confirmed it in FURLS. During the period between initiating the change and confirmation, the original U.S. Agent technically remains the designated contact. For this reason, manufacturers should coordinate with both the outgoing and incoming agent to minimize any gap in coverage, and should not terminate the relationship with the existing agent until the new designation is confirmed in FURLS.

It is also worth noting that the U.S. Agent change must be made in FURLS directly — informal communications to FDA or to the new agent alone do not constitute a change of designation. The FURLS system is the authoritative record of who serves as U.S. Agent for each registered foreign establishment.

The Import for Export Exemption

One statutory exemption from foreign establishment registration deserves attention, because it is often misunderstood. Under Section 801(e) of the FD&C Act, devices that are imported into the United States solely for purposes of being exported — that is, they are incorporated into a product that is then shipped out of the U.S. and never sold domestically — may be exempt from the device registration and listing requirements that would otherwise apply.

This exemption is narrow. It applies only when the imported device is not sold or distributed in U.S. commerce in any way before export. A device that is incorporated into a system or product sold to U.S. customers — even as a component — does not qualify. Manufacturers relying on this exemption should document the basis carefully, as FDA may request evidence that the exemption applies. When the exemption is legitimately in place, the foreign establishment is still subject to other FD&C Act requirements; registration is just not among them.

Frequently Asked Questions

Do all foreign medical device manufacturers need FDA registration?

Yes — with a narrow exception. Any foreign establishment that manufactures, processes, or packages a finished medical device for commercial distribution in the United States must register with FDA under 21 CFR Part 807. The exception is the import for export provision: if a device is imported solely to be incorporated into a product that is then exported out of the U.S. without being sold domestically, FDA registration may not be required. That exception is narrow and fact-specific; if you are selling or distributing devices to U.S. customers in any form, registration is required.

What does a U.S. Agent actually do?

The U.S. Agent is the designated point of contact between FDA and the foreign manufacturer. FDA uses the U.S. Agent to deliver import alerts, warning letters, inspection notices, and other official communications. The U.S. Agent is also responsible for forwarding those communications to the foreign establishment promptly. Critically, the U.S. Agent must be reachable by FDA during U.S. business hours — an unresponsive or unreachable U.S. Agent can trigger regulatory action against the foreign establishment.

Can a foreign manufacturer be its own U.S. Agent?

No. FDA regulations require that the U.S. Agent reside in the United States or maintain a place of business in the U.S. A foreign manufacturer cannot designate itself, a foreign affiliate, or a foreign individual as its U.S. Agent. The U.S. Agent must be a U.S.-based person or entity that FDA can physically contact within the United States. This is one of the reasons foreign manufacturers typically work with a regulatory consulting firm or specialized U.S. Agent service.

What happens if my U.S. Agent is unreachable?

An unreachable U.S. Agent is a serious compliance problem. FDA may place the foreign establishment on an import alert, which means U.S. Customs can detain shipments from that facility at the border without physical examination — a designation that can take months to resolve. FDA may also issue warning letters citing failure to designate an adequate U.S. Agent. If you change U.S. Agents, the new designation must be updated in FURLS before the change takes effect — there is no grace period during which the old agent continues to serve.