INTERNATIONAL TRADE LAW
How to Import Medical Devices into the U.S.
Importing a medical device into the United States requires FDA establishment registration and device listing, a U.S. initial importer of record, and the right premarket clearance for the device’s risk class — all in place before the shipment reaches the port. The Food and Drug Administration regulates devices under the Federal Food, Drug, and Cosmetic Act, and customs entry of a device is reviewed against FDA’s databases. If the registration, listing, or clearance is missing, the entry can be detained and refused.
Start With the Device’s Risk Class
Every device falls into one of three FDA risk classes, and the class drives what you must do before import.
| Class | Risk level | Typical premarket pathway |
|---|---|---|
| Class I | Low | Most are exempt from premarket review; general controls apply |
| Class II | Moderate | 510(k) premarket notification (substantial equivalence) |
| Class III | High | Premarket Approval (PMA) — the most rigorous review |
A 510(k) is a premarket notification showing the device is substantially equivalent to a legally marketed “predicate” device. Most Class II devices, and a few Class I, need 510(k) clearance before they can be marketed or imported. Class III devices generally require an approved PMA. A genuinely novel low-to-moderate-risk device with no predicate can sometimes use the De Novo classification route instead. Identify the class and the pathway first — everything else depends on it.
Register the Establishment and List the Device
Firms involved in producing or importing a device for the U.S. market must register annually with FDA and list their devices through the FDA Unified Registration and Listing System (FURLS). This registration is separate from 510(k) clearance or PMA approval — clearing a device does not register the company, and registering the company does not clear the device. Establishment registration carries an annual user fee that FDA updates each fiscal year.
A foreign manufacturer must register, list its devices, and designate a U.S. Agent who serves as FDA’s point of contact. The initial importer — the U.S. party that first receives the device and furthers its distribution — must also register, though initial importers are not required to file the device listing themselves. Confirm in writing who is playing which role before goods ship, because the entry filing depends on it.
Get the Entry Filing Right
When a device arrives, the importer or customs broker transmits the FDA entry data electronically through CBP’s Automated Commercial Environment. The filing identifies the product with an FDA product code and supplies Affirmation of Compliance codes — the registration number, the device listing number, and the 510(k) or PMA number where applicable. FDA reviews the entry against its registration and listing database. If the data matches and the device is admissible, it is released; if the firm is not registered, the device is not listed, or required clearance is missing, FDA may detain the shipment and ultimately refuse admission.
Because devices are also goods, they still need a correct Harmonized Tariff Schedule classification for duty purposes — a separate determination from the FDA review. See our guide to classifying imported goods.
Don’t Forget Labeling and Quality Systems
Two more requirements sit behind the entry. First, most devices must carry a Unique Device Identifier (UDI) and be submitted to FDA’s Global UDI Database, and device labeling must meet FDA’s content rules. Second, device manufacturing must follow FDA’s quality system requirements at 21 CFR Part 820. These obligations fall on the manufacturer, but an initial importer who discovers a labeling or quality gap after entry can end up holding noncompliant inventory — so verify them as part of supplier due diligence, not after the fact.
Importing other FDA-regulated products follows a related but distinct path; compare our guides on importing food products and the broader practice overview at international trade law.
Frequently Asked Questions
Does FDA “approve” every imported device? No. Most Class I devices are exempt from premarket review, most Class II devices need 510(k) clearance, and only Class III devices generally require Premarket Approval. The requirement tracks the device’s risk class.
Who has to register — the foreign maker or the U.S. importer? Both. The foreign manufacturer registers, lists its devices, and names a U.S. Agent; the U.S. initial importer also registers. Registration is annual through FURLS and carries a user fee.
What happens if registration or clearance is missing at entry? FDA reviews the entry against its databases. If the establishment is not registered, the device is not listed, or required clearance is absent, FDA can detain the shipment and refuse admission.
Is the HTS code the same as the FDA review? No. The Harmonized Tariff Schedule classification sets the duty and is a customs determination; the FDA review checks registration, listing, and clearance. A device import has to satisfy both.
Importing medical devices? Reidel Law Firm prepares flat-fee import/export compliance memos and advises importers on FDA entry, registration, and customs compliance with direct attorney access. Get an import compliance memo →
