Foreign Medical Device Establishment Registration

Purchase the item on this page to register or renew registration for your foreign medical device establishment for 2025. The government registration fee for FY 2025 has increased to $9,280. Total price will be $10,380 ($1,100 service fee + $9,280 government registration fee).

Please note that unless all information is received and payments have cleared by December 16, 2024, we cannot guarantee registrations will be submitted and processed before the deadline of December 31, 2024. Orders completed after December 16 may be processed in January 2025.

Medical Device Establishment Registration Requirement

Manufacturers (both domestic and foreign) and initial distributors (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 drug 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 an 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. The FDA registration fees are as follows:

• Fiscal Year 2024: $7,653 (October 1, 2023 - September 30, 2024)
• Fiscal Year 2025: $9,280 (October 1, 2024 - September 30, 2025)

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