Foreign Medical Device Establishment Registration

Regular price $5,574.00

Purchase the item on this page to register or renew registration for your foreign medical device establishment for 2018. Please note the price includes a $950 service fee and a $4624 government registration fee for FY 2018.

Registration for 2019 will open October 1, 2018. The government registration fee for FY 2019 has increased to $4884. Total price will be $5484 ($600 service fee + $4884 government registration fee).

 

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 2018: $4,624 (October 1, 2017 - September 30, 2018)
  • Fiscal Year 2019: $4,884 (October 1, 2018 - September 30, 2019)

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

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