Importing Medical Devices into the US

by | Feb 8, 2021 | Compliance, FDA, Imports, Quality, Quality Systems

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.


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

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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