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Purchase the item on this page to register or renew registration for your foreign medical device establishment for 2023.

The government registration fee for FY 2023 has increased to $6,493. Total price will be $7,493 ($1,300 service fee--US agent service included + $6,493 government registration fee).

Medical Device Establishment Registration Requirement:

Manufacturers (both domestic and foreign) and initial importers of medical devices must register their establishments with the FDA on an annual basis. Every importer of medical device products to the United States must provide to the FDA with the medical device facility registration number for the foreign medical device manufacturer and importer/distributor. Failure to provide this information will result in a detention or refusal of the medical device products.

U.S. Agent Designation:

In addition to registering their medical device facility, foreign manufacturers must also designate a U.S. Agent. The U.S. Agent is a person or entity that maintains a physical address in the United States who can serve as the facilities representative before the FDA.

FDA Medical Device Fees:

Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations.
FDA registration fees are as follows:

  • Fiscal Year 2023: Fees will be announced by October 1, 2022 (October 1, 2022 - September 30, 2023
  • Fiscal Year 2022: $5,672 (October 1, 2020 - September 30, 2021)

Registration Renewal:

Medical device facility registration information must be verified annually between October 1st and December 31st of each year.

FDA Foreign Medical Device Establishment Registration and Renewal

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