America Is Tightening Its Borders — What Does It Mean for Foreign Medical Device Manufacturers?

As U.S. federal enforcement becomes more focused on border security, importer accountability, and supply chain transparency, foreign medical device manufacturers may need to take a closer look at how their products actually enter the U.S. market.

Over the past year, much of the public discussion around U.S. border enforcement has centered on immigration.

Immigration enforcement has clearly become a major federal priority. At the same time, however, the federal government is also tightening its approach toward another category crossing U.S. borders: imported goods.

For foreign medical device manufacturers, this second development may have a much more direct impact on day-to-day business.

On June 3, 2026, the White House issued Executive Order 14411, “Strengthening Customs Enforcement.” The order directs the Department of Homeland Security and U.S. Customs and Border Protection (CBP) to strengthen importer accountability, increase transparency, enhance vetting, and revise requirements affecting Importers of Record, including foreign IORs.

Not every requirement described in the order is already fully implemented. Many provisions require DHS and CBP to develop or revise regulations, policies, and guidance within specified implementation periods.

However, the direction of U.S. policy is becoming increasingly clear:

Foreign companies should expect greater scrutiny of who is importing products, what is being imported, and whether the parties involved in the transaction are properly identified and compliant.

For medical device companies, this is particularly important because importing a medical device into the United States already involves both FDA and customs requirements.

FDA Clearance Is Only Part of U.S. Market Entry

Many foreign manufacturers understandably focus first on whether their medical device requires FDA clearance.

Depending on the device classification and intended use, a product may require a 510(k), PMA, De Novo authorization, or may qualify for an exemption.

But receiving the appropriate FDA marketing authorization is not the end of the U.S. market-entry process.

Foreign medical device manufacturers must also comply with applicable requirements involving establishment registration, device listing, quality management systems, labeling, Medical Device Reporting, and other postmarket obligations. FDA also requires a foreign establishment to designate a U.S. Agent as part of its registration.

And once the device physically enters the United States, another layer of compliance becomes critical.

Import compliance.

What Happens When a Medical Device Reaches the U.S. Border?

When an FDA-regulated medical device is imported, information about the shipment is transmitted to FDA.

FDA can verify the declared manufacturer, shipper, importer, registration status, and device listing information against its databases.

According to FDA, if the submitted import information matches the agency's registration and listing records, compliance can be verified. If information does not match, FDA may request additional information or detain the product. If required registration or listing is missing, the product may be subject to refusal.

This means that even a legally marketed medical device can encounter import problems when the parties and information surrounding the shipment are not properly structured.

For example:

• Is the foreign manufacturing establishment actively registered?

• Is the device properly listed?

• Does the product require a 510(k), PMA, or other authorization?

• Does the shipment information correctly identify the manufacturer?

• Is the appropriate U.S. importer properly registered?

• Do the product code and device description correspond with FDA records?

• Is the correct party acting as Importer of Record?

• Are the customs broker and importer working from accurate regulatory information?

These questions become increasingly important in a more enforcement-focused import environment.

U.S. Agent, Initial Importer, and Importer of Record Are Different Roles

One of the most common areas of confusion for foreign medical device manufacturers is the difference between three parties:

U.S. AgentFDA Initial ImporterImporter of Record

They are not interchangeable.

U.S. Agent

A foreign medical device establishment must designate a U.S. Agent when registering with FDA.

The U.S. Agent primarily serves as a communication liaison between the foreign establishment and FDA. FDA may communicate with the U.S. Agent regarding matters such as regulatory questions and inspection coordination.

The U.S. Agent does not automatically become the importer of the product.

FDA Initial Importer

FDA defines an Initial Importer as an importer that furthers the marketing of a device from a foreign manufacturer toward the ultimate consumer or user without repackaging or otherwise changing the device package or labeling.

FDA states that an Initial Importer must have a physical address in the United States staffed by individuals responsible for ensuring that imported devices comply with applicable FDA requirements. Initial Importers are also subject to FDA establishment registration requirements.

FDA registration records also connect foreign establishments and their known U.S. importers: foreign establishments exporting devices to the United States must identify known U.S. importers, while Initial Importers identify the foreign manufacturers whose devices they import.

Importer of Record

The Importer of Record, or IOR, is primarily a customs role.

The IOR is responsible for customs entry and compliance responsibilities associated with importing merchandise into the United States.

This role is now receiving particular federal attention.

The June 2026 Executive Order directs DHS and CBP to revise IOR eligibility requirements and calls for measures involving increased bonding or domestic asset requirements, additional identification and ownership disclosures, compliance-based “good standing,” enhanced vetting, and risk-based classifications of importers.

The order also specifically calls for tighter treatment of foreign IORs, including restrictions on informal entry and additional conditions for formal entry.

For foreign medical device manufacturers currently acting as their own foreign IOR—or considering doing so—these developments deserve close attention.

Why Foreign Medical Device Manufacturers Should Review Their Import Structure Now

Historically, some foreign manufacturers have treated import logistics as something to resolve after the FDA portion of market entry was completed.

The manufacturer obtains a 510(k), registers the facility, lists the device, signs an agreement with a distributor, and then assumes that a customs broker or logistics company will handle the rest.

That approach can create gaps.

A customs broker, U.S. Agent, distributor, Initial Importer, and IOR may all participate in bringing a device to market, but each role has different responsibilities.

As federal enforcement increasingly focuses on importer identity, compliance history, ownership transparency, supply chains, and accurate import information, manufacturers should know before shipment exactly which entity is responsible for each part of the transaction.

Executive Order 14411 also directs CBP toward enhanced vetting of parties involved in importing goods, including foreign IORs, IOR affiliates, customs brokers, custodians of bonded merchandise, and freight forwarders. It further calls for heightened disclosures regarding imported goods and their supply chains.

For a regulated product such as a medical device, that reinforces the importance of consistency between commercial, customs, and FDA information.

Five Questions to Ask Before Your Next U.S. Shipment

Foreign medical device manufacturers should consider reviewing the following:

1. Is our FDA establishment registration current?

Foreign establishments must register before exporting devices to the United States.

2. Is every device being commercially imported properly listed and authorized?

Registration alone does not mean that a medical device is FDA-approved or cleared. FDA specifically states that establishment registration or device listing does not itself constitute FDA approval.

3. Who is our FDA Initial Importer?

Foreign manufacturers should understand which U.S. entity is actually performing the Initial Importer function and whether that entity is properly registered.

4. Who is our Importer of Record?

Do not assume the Initial Importer, distributor, customs broker, or U.S. Agent automatically serves as IOR.

The customs structure should be established separately and deliberately.

5. Do our FDA, customs, shipping, and commercial records tell the same story?

Manufacturer identity, product information, model information, regulatory status, importer information, and shipment documentation should be reviewed for consistency before goods reach the United States.

The Bigger Picture: U.S. Market Entry Is Becoming More Than an FDA Project

The recent focus on U.S. border enforcement is broader than immigration.

For companies importing commercial goods, the federal government is simultaneously emphasizing accountability at the border, importer transparency, stronger customs enforcement, and greater scrutiny of foreign import structures.

That does not mean that FDA has suddenly created new medical device import requirements because of immigration policy.

These are separate regulatory areas.

But they are developing within a broader federal environment in which compliance, traceability, and accountability of foreign parties entering the U.S. market are receiving greater attention.

For foreign medical device manufacturers, the practical lesson is straightforward:

Do not wait until a shipment is at the port to determine who is responsible for importing it.

FDA authorization, establishment registration, device listing, U.S. Agent designation, Initial Importer arrangements, IOR responsibilities, and customs entry should be viewed as parts of one coordinated U.S. market-entry strategy.

As the U.S. import environment continues to evolve, manufacturers with a clearly defined and compliant structure will be better positioned to reduce delays, avoid preventable import issues, and maintain a stable path to the U.S. market.

This article is provided for general informational purposes and does not constitute legal advice.