Foreign medical device manufacturers must register annually with FDA, list their devices, and appoint a U.S. Agent for official communications. Learn key obligations, agent responsibilities, and compliance tips to ensure smooth importation.
If you’re a medical device manufacturer located outside the United States and you intend to export your devices to the U.S., you have a few additional FDA requirements to meet. Foreign establishments must register and list just like U.S. companies, and importantly, they must designate an official United States Agent for FDA communications. This section explains those obligations and offers tips to ensure compliance and smooth importation.
The FDA does not give foreign manufacturers a pass on registration – in fact, they are very much included. Any foreign establishment engaged in the manufacture, processing, or packaging of a device that is imported into the U.S. must register annually with FDA and list its devices, just as a domestic firm would. Practically, the process of registration for a foreign firm is the same (using FURLS) except for a couple of extra data points (like identifying U.S. Agent and U.S. importers). Foreign companies must register before exporting devices to the U.S., meaning you should complete initial registration and listing prior to that first shipment. Additionally, if you are a foreign firm that only exports devices (does not sell domestically in your country), you still must register if those devices land in the U.S. supply chain.
A unique requirement for foreign establishments is the designation of a U.S. Agent. The U.S. Agent is an individual or entity located in the United States who serves as a point of contact between FDA and your company. You are required to provide the name, address, phone, and email of your U.S. Agent as part of your registration. FDA’s system will actually send an email to that person asking them to confirm they agree to be your agent. You can only have one U.S. Agent at a time per establishment. If the agent does not confirm within 10 business days or declines, you’ll be notified to appoint someone else.
Important: The U.S. Agent must have a physical presence in the U.S. – a P.O. box or voicemail-only setup is not acceptable. They need to be reachable during normal business hours.
It could be an independent regulatory consultant, a company that offers U.S. Agent services, an employee of your own company if they reside in the U.S., or even the U.S.-based distributor or importer for your device. There’s no requirement that the agent be a regulatory professional, but given their duties, it’s wise to choose someone knowledgeable in FDA processes.
FDA defines fairly limited but important duties for the U.S. Agent:
It’s worth noting what the U.S. Agent is not responsible for: They are not by default responsible for adverse event reporting, 510(k) submissions, or other regulatory obligations of the foreign firm. (They could separately be hired or delegated to do those things, but that would be a different arrangement). The agent’s role is primarily about accessibility and communication.
Don’t confuse the U.S. Agent with an Initial Importer. An initial importer (as discussed earlier) is essentially your customer or distributor in the U.S. who imports the device and must register themselves. The U.S. Agent, by contrast, might not import or handle the device at all – they could be simply an office that acts as your legal contact. Some companies use their importer/distributor as the U.S. Agent, which is convenient but you should ensure that party is responsive and understands the role. If your distributor is small or not knowledgeable about FDA, you might opt to use a professional regulatory firm as your U.S. Agent instead, to ensure nothing falls through the cracks.
During foreign registration, FDA will ask the foreign establishment to identify all known U.S. importers of their device. This means you should list the companies in the U.S. that will be importing your products. This information helps FDA correlate registrations – e.g., an initial importer registration from Company ABC can be linked to Foreign Manufacturer XYZ’s listing if XYZ named ABC as an importer. Keep this list updated – if you add a new U.S. distributor later, update your registration to include them.
A German device manufacturer has registered and listed their devices. They initially used Distributor A as their U.S. Agent. A year later, they switch to Distributor B and terminate Distributor A. If they forget to update the U.S. Agent, FDA might still be contacting Distributor A with important info (like an upcoming inspection of the German site). Distributor A, no longer invested, ignores these. FDA doesn’t get a response – this could lead them to mark the firm as unresponsive and possibly detain products or escalate enforcement. All because the agent info wasn’t updated. The fix is simple: log into FURLS, enter the new agent info, and the new agent confirms. So always keep that current.
If you’re familiar with European regulations, the U.S. Agent role is somewhat analogous to the EU Authorized Representative concept, though not exactly the same. Both serve as in-market liaisons. The difference is the U.S. Agent doesn’t have to handle complaints or keep a tech file like an EU-AR would; it’s mainly for FDA communication and emergencies.
Just a reminder – if you as a foreign firm also have set up a U.S. subsidiary that acts as the importer of record, that U.S. entity should register as an Initial Importer (and it can serve as your U.S. Agent too if you want). The initial importer will have to list your foreign manufacturer in their registration[31]. Ensure that linkage is done so that when your products enter the U.S., the system recognizes the connection (the foreign manufacturer registration, the importer registration, and the device listing should all tie together).
In summary, foreign device manufacturers must essentially play by the same rules as domestic ones: register every year, list all devices, pay the fee, and additionally maintain a reliable U.S. Agent. By doing so, you’ll find that interacting with FDA (and getting your products through customs) can be as straightforward as it is for a U.S. company. If you neglect these requirements, FDA has strong mechanisms (like import refusals) to enforce compliance on foreign firms. So set up a good U.S. Agent relationship, keep your U.S. contacts updated, and your U.S. market entry should go smoothly from a regulatory standpoint.
