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
- 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
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1Importing Medical Devices and Radiation-Emitting Electronic 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