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Medical Device Establishment Registration

All Medical Device Establishment Registrations must be renewed yearly. Registration for 2018 is now open!



Domestic Medical Device Establishment Registration
$600

For domestic medical device establishment registration with the U.S. FDA for 2018. $600 service fee plus $4,624 FDA government registration fee.



Foreign Medical Device Establishment Registration
$950

For foreign medical device establishment registration with the U.S. FDA and U.S. Agent services for 2018. $950 service & U.S. Agent fee plus $4,624 FDA government registration fee.

 

About Medical Device Establishment Registrations

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA on an annual basis. Medical device facility registration information must be verified annually between October 1st and December 31st of each year.

 

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. 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.

 

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

 

FY 2018:
Domestic establishment registration: $5,224 ($4,624- government registration fee + $600 service fee)
Foreign establishment registration: $5,574 ($4,624- government registration fee + $950 service fee)

 

Most medical device establishments that are required to register with the FDA are also required to list the medical devices that are manufactured at the facility and the activities that are performed on those devices. FDA Solutions Group’s medical device specialists help businesses comply with U.S. FDA medical device registration and listing requirements.