Do all imported medical devices need a 510(k)?

No. Most Class I devices are exempt. Class II devices usually require a 510(k) premarket notification, and Class III devices usually require premarket approval (PMA). The requirement depends on the device’s classification.

Who has to register with FDA to import a device?

The foreign manufacturer must register, list its devices, and designate a U.S. agent. The U.S. initial importer must also register. Missing registrations are a frequent cause of entry delays.

What changed with the QMSR in 2026?

Effective February 2, 2026, FDA’s quality system rule in 21 CFR Part 820 incorporates ISO 13485:2016 by reference and is now called the Quality Management System Regulation (QMSR), replacing the older Quality System Regulation.

Can a device clear CBP but still be stopped?

Yes. Customs admissibility and FDA admissibility are separate. FDA reviews device entries independently and can detain or refuse a shipment even after it clears customs. The costly failures in device imports are usually paperwork and premarket gaps — an unregistered manufacturer, a device outside its clearance, a supplier still on the old quality standard — and they surface as a detention, not a warning. Reidel Law Firm helps importers map FDA and customs requirements before the first shipment, on flat-fee terms. Get an import compliance memo.

INTERNATIONAL TRADE LAW

Importing Medical Devices: FDA Rules for Imports

Schuyler 'Rocky' Reidel July 17, 2023 5 min read

To import a medical device into the United States, the device must clear FDA’s premarket requirements for its risk class, the manufacturer and importer must be registered and listed with FDA, and the shipment must pass FDA review at entry. Customs admissibility and FDA complianc