The US Food and Drug Administration regulates the import of medical devices into the US to ensure compliance. Foreign manufacturers must register, list their devices, have a quality system, submit premarket notifications or approvals, and comply with labeling, reporting, and other requirements. They must also designate a US agent and are subject to FDA enforcement. Imported radiation devices have additional radiation safety standards. All imports must also meet Customs and Border Protection requirements to clear customs, or they may be detained. Companies importing without understanding the full process risk financial penalties.

1. Importing Medical Devices into the US
By: Nikita Angane
The US Food and Drug Administration has the responsibility to ensure that medical
devices being imported into the US comply with the applicable regulations. A foreign
manufacturer, defined as a manufacturer located outside of the US, must comply at a minimum
with the applicable regulations as stated below to import their device in the US.1
The basic regulatory requirements include:1
 Establishment registration
 Medical Device Listing
 Quality System
 Premarket Notification [510(k)], unless exempt, or Premarket Approval
 Labeling
 Medical Device Reporting
A foreign manufacturer is also required to designate a US-based agent at the time of registration
and is subject to the same FDA enforcement as a US-based manufacturer would be. 1
Foreign manufacturers of a radiation-emitting electronic product must also meet the radiation
safety-related requirements of the Federal Food, Drug, and Cosmetic Act outlined in 21CFR
1000 through 21CFR 1050 which includes requirements for performance standards, labeling,
and submission of radiation safety product reports.1
Additionally, all imported devices must meet the requirements of the U.S. Bureau of Customs
and Border Protection (CBP). The CBP administers the assessment and collection of all taxes,
and fees on imported merchandise, reviewing import entry forms, and administering certain
navigation laws and treaties. Products that do not meet the FDA and the CBP requirements may
be detained upon entry in the US.1
We have seen companies import their products to the US without understanding the complete
process and face huge financial setbacks. Do not let that happen to you!
Call us today at +1 248-987-4497 or email us at info@emmainternational.com to know more
about how we can help you import your product.
1 Importing Medical Devices and Radiation-EmittingElectronic Products into the U.S.- retrieved on 02/04/2021
from https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-
and-radiation-emitting-electronic-products-us#devices