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There are two important points to know when importing medical devices into the United States. First, the foreign manufacturer and the device must meet the FDA requirements that apply before the product can be imported commercially. Second, medical devices that emit electronic product radiation can also be subject to additional radiation-control requirements.
The exact requirements depend on the device. FDA verifies requirements such as establishment registration and device listing at import and, where applicable, premarket submissions such as a 510(k) or Premarket Approval (PMA). FDA can also examine imported devices for compliance with applicable labeling and other requirements.
Firstly, the foreign manufacturer you are importing from must meet the U.S. requirements that apply to the medical device before it can be commercially imported.
Not every medical device follows exactly the same regulatory path. The device classification, intended use, and applicable FDA requirements need to be identified before the shipment leaves the manufacturer.
The requirements that apply depend on the device and the activities performed by the foreign establishment. A U.S. business that meets FDA’s definition of an initial importer also has its own responsibilities, including establishment registration and applicable Medical Device Reporting requirements.
Registration or device listing should not be confused with FDA approval. Whether a device requires premarket clearance or approval is a separate question and depends on the particular device.
Medical Device Reporting (MDR) should not be confused with a document that must be filed for every medical-device shipment.
MDR is a postmarket reporting system for certain medical-device adverse events and product problems. Importers are required to report to FDA and the manufacturer when they become aware that an imported device may have caused or contributed to a death or serious injury. Certain malfunctions that could cause or contribute to a death or serious injury if they recur must be reported to the manufacturer.
FDA generally requires these importer reports within 30 calendar days of becoming aware of the reportable event. MDR reports are now submitted electronically.
You can read more about Medical Device Reporting here.
Not every medical device requires the same premarket submission.
FDA classifies medical devices according to risk and other regulatory considerations. Most Class I devices and some Class II devices are exempt from 510(k) requirements, although other FDA requirements can still apply. Other devices require a 510(k), while certain higher-risk devices require Premarket Approval (PMA).
Other FDA pathways, including De Novo classification and Humanitarian Device Exemptions, can apply in particular circumstances.
The importer and manufacturer should identify the device’s FDA classification and applicable submission requirements before shipping. FDA’s Product Classification database can be used to search by device, product code, or regulation number.
Where a device requires a 510(k) or PMA, FDA verifies the applicable information during import review. FDA states that if a required 510(k) or PMA is missing, the product is subject to refusal.
Approval or authorization in another country does not automatically satisfy the U.S. requirements. FDA states that it does not recognize foreign regulatory approvals as a substitute for applicable FDA requirements.
Medical device manufacturers also need to consider FDA’s manufacturing quality requirements. On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) became effective, replacing the previous Quality System Regulation (QSR) framework.
The QMSR amended the requirements under 21 CFR Part 820 and incorporates the international medical-device quality-management standard ISO 13485:2016 by reference. The regulation applies to finished-device manufacturers subject to its requirements.
In addition to the normal commercial shipment documents, the importer and customs broker need accurate information about the medical device and the businesses involved. Errors in the FDA product code, manufacturer information, or other entry data can cause the shipment to require additional FDA review.
A commercial shipment will commonly involve a Commercial Invoice, Packing List, and Bill of Lading or Air Waybill. For FDA entry purposes, additional information can include the device product code, manufacturer and importer identifiers, establishment registration and device-listing information, and any applicable 510(k) or PMA number.
FDA entry filers can also transmit Affirmations of Compliance and their applicable qualifiers. Some are mandatory depending on the product, while accurate voluntary information can help FDA verify compliance and process the entry more efficiently.
A customs broker can prepare the Customs entry and transmit the applicable FDA entry information provided by the responsible parties.
Some medical devices that emit electronic product radiation are subject to additional FDA radiation-control requirements as well as the medical-device requirements discussed above.
Whether additional import documentation is required depends on the product. FDA requires Form FDA 2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, when a radiation-emitting electronic product is subject to an applicable federal performance standard.
A radiation-emitting product that is not subject to a federal performance standard does not require Form FDA 2877 solely for importation. Importers should therefore identify the specific product and applicable standard rather than assuming that every radiation-emitting medical device follows the same process.
Foreign manufacturers of radiation-emitting electronic products must also comply with the applicable radiation-control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Subchapter C: Electronic Product Radiation Control. Depending on the product, these requirements can include performance standards, labeling, and radiation safety product reporting.
Performance Standards – Certain radiation-emitting products are subject to specific federal performance standards. The requirements depend on the type of product and can address its design, performance, and radiation-safety features.
Proper Labeling – Products subject to applicable radiation performance standards can also have certification, identification, and other labeling requirements. The exact labeling depends on the product and the standard that applies.
Radiation Safety Reports – Manufacturers of applicable radiation-emitting products have reporting and recordkeeping responsibilities. A foreign manufacturer may need to submit a radiation safety product report to FDA, after which FDA assigns an accession number. An importer may submit the report on behalf of the foreign manufacturer.
Read more about the Electronic Product Radiation Control here.
FDA compares the information transmitted at entry with its registration, listing, and premarket databases. Missing or inaccurate identifiers can trigger additional review, while missing required registration, listing, or premarket authorization can result in additional review, detention or refusal of entry.
For this reason, it is worth confirming the FDA information before the shipment leaves the foreign manufacturer rather than trying to resolve discrepancies after arrival.
With A1 Worldwide Logistics, we work to remove as many hurdles as possible between you and your products. Medical-device imports can involve both Customs and FDA requirements, so it is better to review the available shipment and FDA information before the goods leave the manufacturer.
If you want a smooth import of your medical devices, please give us a call before the shipment begins. We may be able to help avoid delays caused by incomplete Customs or FDA entry information and save you a lot of headaches and setbacks in accessing your devices.
Regulatory note: This guide provides general information and is not legal or FDA regulatory advice. U.S. import rules and agency requirements can change and may vary by device, intended use, manufacturer, country of origin and shipment. Importers should confirm current requirements with FDA and, where appropriate, a licensed customs broker, qualified FDA regulatory professional or legal adviser before shipping.
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