How To Export Medical Devices to the USA

clock 11/02/2026 By Luana Oliveira clock 6 Minutes

To successfully export medical devices to the United States, international manufacturers must navigate three critical regulatory pillars: determining the product's risk classification (Class I, II, or III), completing establishment registration and product listing with the FDA (Food and Drug Administration), and mandatorily appointing a US Agent.

Without following this compliance roadmap, your cargo will be detained at customs, regardless of product quality or competitive pricing.

Success in the American market is not just about the sale, it is about the regulatory preparation that precedes the shipment. The good news? You don’t have to face this bureaucracy alone.

The Potential of the American Healthcare Market

It is no exaggeration to say that the United States is the "Gold Standard" of the healthcare sector. We are talking about the largest market in the world, responsible for approximately 40% of global medical device consumption.

For global exporters, this represents a level of scalability that is hard to find elsewhere.

However, entering this market requires more than a great product, it demands professional compliance.

The American buyer (whether a hospital, a pharmacy chain, or a distributor) prioritizes legal security. They need to be certain that your company is compliant and that your products strictly follow local regulations.

The "Gatekeeper" of the Market: Understanding the FDA

Unlike many local markets where regulatory processes can be opaque, the FDA is extremely technical and predictable. If you follow the rules, you get in.

The FDA’s role is to ensure the safety and efficacy of medical products. For those accustomed to complex local bureaucracies, the American system may even seem more agile in some aspects, but it is relentless in its enforcement.

Pro-Tip: Do not try to find "workarounds." The American system is built on trust and verification. Any attempt to bypass steps can lead to a permanent ban from the market.

To deepen your understanding of this regulatory body, I recommend reading our detailed article on what is the FDA and how does it work?

Technical Step-by-Step for Exporting

Let’s break down the process into manageable parts to help you plan your entry.

1. Device Classification

Everything starts here. The FDA classifies devices into three categories based on the risk they pose to the patient:

  • Class I (Low Risk): Simple items like bandages, certain examination gloves, and manual surgical brushes. Most are exempt from pre-market notification.
  • Class II (Moderate Risk): This includes powered wheelchairs, infusion pumps, and some diagnostic equipment. These usually require a pre-market notification known as a 510(k).
  • Class III (High Risk): Life-sustaining or implantable devices, such as pacemakers. These require Pre-Market Approval (PMA), a much more rigorous and expensive process involving clinical trials.

If you misclassify your device, the entire subsequent process will be compromised.

2. Notificação Pré-Mercado 510(k)

If your product is Class II (very common for exporters), you will likely need to submit a 510(k).

Essentially, you must prove to the FDA that your device is "substantially equivalent" to a product already legally marketed in the US (known as a predicate device).

You don’t need to prove your product is "better," only that it is as safe and effective as the approved competitor.

3. Establishment Registration and Listing

Every facility involved in the production and distribution of medical devices for the US must register annually with the FDA and pay the required fee. In addition to registering the company, you must list every single product intended for export.

This is a critical bureaucratic step. To avoid costly mistakes during this phase, you should seek professional FDA registration and listing services to ensure your data is processed correctly.

4. The US Agent

This is a mandatory requirement for all foreign companies. You cannot export to the US without a designated US Agent.

Note: The US Agent is not a sales representative. They will not sell your product. Instead, they serve as the official point of contact between the FDA and your company. If the FDA has an urgent question or wishes to schedule a factory inspection in your home country, they will contact the US Agent. They must reside in the US and be available during standard business hours.

The Importance of Specialized Assistance

Many entrepreneurs hesitate when faced with the complexity of finding a reliable US Agent or filling out technical FDA forms in legal English. The risk of filing incorrect information and having your shipment seized is real.

To mitigate these risks and accelerate market entry, the most efficient strategy is to hire a specialized service that centralizes these obligations.

B2B Trade Center offers comprehensive FDA services for medical devices, allowing you to:

  • Appoint an official US Agent.
  • Handle establishment registration and product listing.
  • Receive technical consultancy for regulatory alignment.

Having a partner who masters American legislation transforms a bureaucratic barrier into a competitive advantage.

How to Find Buyers in the USA?

With the regulatory side handled, the commercial challenge begins. The American market is vast and fragmented.

You can sell to GPOs (Group Purchasing Organizations), regional distributors, or even via B2B e-commerce.

Many international manufacturers fail because they attempt to handle everything solo, literally going door-to-door. The smartest way to gain visibility and reach qualified leads is through digital tools.

Using a global trade ecosystem is essential to connect your supply with buyers who are already searching for your products. Discover why using a foreign trade platform is the key to global expansion.

Consolidating Your Brand in the Global Health Market

Exporting medical devices to the USA requires planning, investment, and rigorous technical compliance. The barrier to entry is high, but that is exactly what protects the market and ensures better margins for those who successfully cross it.

By utilizing specialized services to handle the regulatory burden, your brand gains the agility and security needed to win the trust of American hospitals and distributors.

Frequently Asked Questions (FAQ)

1. Do I need to open a company in the USA to export medical devices?

Not necessarily. You can export directly from your home country, provided you appoint a US Agent to represent your company before the FDA.

2. Does my local health certification work for the United States?

No. The FDA does not automatically validate foreign approvals. While your technical data and clinical tests may be reused in your American dossier, the approval process must be initiated from scratch with the FDA.

3. What does a US Agent actually do?

The US Agent is the communication link between the FDA and your foreign company. They must be available for FDA inquiries and assist in scheduling inspections. They do not act as a commercial seller.

4. How long does FDA approval take?

It depends on the risk class. Class I (exempt) products can be exported shortly after registration. For Class II (via 510k), the FDA has a 90-day goal for review, though total preparation can take several months.

5. How can I hire FDA and US Agent services?

Specialized foreign trade firms offer complete packages. For instance, B2B Trade Center provides specific solutions for the medical device segment, covering everything from the US Agent role to full registration.