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Importing a medical device into the US is not a single filing. FDA expects the foreign manufacturer, the importer and the product itself to meet its device rules before, during and after a shipment arrives, and FDA reviewers compare what the entry says against what FDA already holds on file. This page walks through that sequence for buyers, importers and clinic or distributor staff. It describes general regulatory requirements; it is not legal or medical advice.
What it is: importing a medical device
For FDA purposes, importing a device means bringing it into the United States under an entry that FDA reviews alongside US Customs and Border Protection (CBP). The question FDA asks is whether the device is legally marketed in the United States and whether the firms named on the entry are known to FDA.
Who uses this process: foreign manufacturers shipping to the US, importers and distributors that bring devices in, and clinic, laboratory or hospital buyers who source devices from abroad.
Legal marketing pathways FDA names
FDA’s page on importing medical devices and radiation-emitting products describes a legally marketed finished device as one that has a pathway such as the following. Which one applies depends on the device.
| Pathway | How FDA words it | What it means at import |
|---|---|---|
| 510(k) | 510(k) clearance | If the device requires a 510(k) and lacks one, it is subject to refusal |
| De Novo | De Novo authorization | Counts as legally marketed |
| PMA | Premarket Approval application approval | If the device requires a PMA and lacks one, it is subject to refusal |
| Exempt | Device exempt from premarket submission | Counts as legally marketed; registration and listing still apply |
Source: FDA, Importing Medical Devices and Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S. (see Sources).
What FDA checks when a device is offered for import
Short answer: an entry filed with US Customs and Border Protection (CBP) for an FDA-regulated product is also sent electronically to FDA for review. FDA’s own page states that it verifies, as applicable, establishment registration, device listing and, in some cases, a premarket submission (510(k) or PMA). Entry reviewers compare the declared manufacturer, importer, product description and Affirmation of Compliance codes with FDA’s data.
Entry data submitted through CBP’s Automated Commercial Environment (ACE) includes country of origin, product code, manufacturer, shipper, affirmations of compliance and the HTS code. At entry FDA looks for a registered manufacturer, shipper and importer and a listed product. The listing number has to be obtained from the firm that listed the device.
Who must register and list: manufacturer, initial importer, wholesale distributor
Establishment registration and medical device listing are the basic requirements. A foreign manufacturer must designate a United States agent as part of its initial and updated registration information (FDA, Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S.).
| Requirement | Who it applies to | Source |
|---|---|---|
| Establishment registration and device listing | Covered persons, including one who acts as an initial importer as defined in 21 CFR 807.3(g) | 21 CFR 807.20(a)(5) |
| Listing by giving the manufacturer’s name and address | An initial importer that did not initiate or develop the device specifications and did not repackage or relabel it | 21 CFR 807.20 |
| No registration or listing requirement | A wholesale distributor that does not manufacture, repackage, process or relabel the device | 21 CFR 807.20(c) |
| US agent designated in the registration | Foreign manufacturers | FDA importing page (01/30/2026 version) |
| Medical Device Reporting (MDR) event file for each adverse event | Importers | FDA importing page (01/30/2026 version) |
The roles of the initial importer and the importer of record are different; see initial importer vs importer of record for medical devices and the guide to the importer of record. The registration and listing records themselves are covered in the FDA registration and listing database.
Before, during and after import
FDA states that foreign establishments must comply with the applicable regulations before, during and after importing. In practice that gives three stages.
Before the shipment
- Confirm the device is legally marketed in the United States. FDA describes this as having a 510(k) clearance, a De Novo authorization, a PMA approval, or being exempt.
- Confirm the manufacturer’s registration and the device listing, and obtain the listing number from the listing firm.
- Identify who will be the importer on the entry and who is the foreign manufacturer’s US agent.
During entry
- The entry is filed with CBP and is transmitted electronically to FDA. FDA compares the manufacturer, shipper, importer, product code and Affirmation of Compliance codes with its own records.
- Customs aspects such as the bond, tariffs and origin marking are handled with CBP: see customs bonds, country of origin marking for imported medical devices and Section 301 tariffs on medical products.
After entry
- An importer is required to report incidents in which a device may have caused or contributed to a death or serious injury, and must maintain an MDR event file for each adverse event. Complaints are forwarded to the manufacturer.
Why shipments are detained or refused
Short answer: a missing registration, missing listing, or missing required 510(k) or PMA means the product is subject to refusal. Information that does not match FDA’s data may lead FDA to gather additional information or to detain the product. FDA’s second importing page also says products that do not meet its regulatory requirements may be detained upon entry.
| Situation at entry | FDA’s stated consequence | Source |
|---|---|---|
| Registration or listing missing | Subject to refusal | FDA, Importing Medical Devices |
| Required 510(k) or PMA missing | Subject to refusal | FDA, Importing Medical Devices |
| Declared information does not match FDA data | FDA may gather more information or may detain the product | FDA, Importing Medical Devices |
FDA also lists detention without physical examination (DWPE) through its import alert database among its tools, alongside field exams and sample analysis. FDA publishes a page of common entry errors for medical devices, which is a practical checklist for filers.
Rules that are often missed
- Finished devices must be legally marketed even if for export only. FDA states that an entity may not import a finished device that is not legally marketed in the United States, including when it is imported solely for subsequent export. Parts, components and subassemblies may be imported for further processing.
- Import for Export is not warehousing. FDA states that an entity may not use the Import for Export provision for warehousing articles in the United States.
- Wholesale distributors are outside registration and listing only while they do not manufacture, repackage, process or relabel (21 CFR 807.20(c)).
Common mistakes
- Declaring a manufacturer, shipper or importer on the entry that is not the registered establishment FDA has on file.
- Not having the listing number from the firm that listed the device.
- Treating a distributor who relabels or repackages as a wholesale distributor; the 807.20(c) exemption does not cover that.
- Ignoring post-entry duties such as the importer’s MDR event file.
FAQ
How do I import medical equipment from China?
FDA’s rules do not depend on the country: the manufacturer must be registered, the device listed, and a required 510(k) or PMA in place, and the entry data must match FDA’s records. Tariff and customs questions are separate; see the Section 301 and customs bond guides linked above.
Do I need FDA approval to import a medical device?
It depends on the device. FDA describes a legally marketed device as one with a 510(k) clearance, a De Novo authorization, a PMA approval, or one that is exempt. A device that needs a premarket submission and lacks it is subject to refusal at entry.
Can I import a device only to re-export it?
Not if it is a finished device that is not legally marketed in the United States. FDA states this applies even when the device is imported solely for subsequent export.
Does an importer have duties after the goods clear?
Yes. FDA states an importer must report incidents where a device may have caused or contributed to a death or serious injury and must maintain an MDR event file for each adverse event.
Where does the logistics side fit?
Freight, storage and delivery planning are covered in medical supply logistics.
Sources
- FDA, Importing Medical Devices (page content current as of 10/09/2024; checked 2026-10-31).
- FDA, Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S. (current as of 01/30/2026; checked 2026-10-31).
- 21 CFR 807.20, Who must register and submit a device listing (checked 2026-10-31).
