Domestic Medical Device Establishment Registration

Purchase the item on this page to register or renew registration for your domestic medical device establishment for 2026. The government registration fee for FY 2026 has increased to $11,423. Total price will be $12,523 ($1,100 service fee + $11,423 government registration fee) Please note that unless all information is received and payments have cleared by Friday December 12, 2025, we cannot guarantee registrations will be submitted and processed before the deadline of December 31, 2025. 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 drug manufacturer and importer/distributor. Failure to provide this information will result in a detention or refusal of the medical device produ