Medical Device FDA Establishment Registration

Our team of experts can help with your FDA establishment registration for medical devices. The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. Once you have paid the fee, the registration process can be finalized.

FDA establishment registration

Why is Medical Device Facility Registration Required?

Registering medical device establishments  with the FDA annually is a must for every domestic and foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to the US to provide the FDA with the medical device facility establishment number for foreign manufacturers and importers/distributors.

Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration.

What is FURLS?

FURLS is an acronym that stands for FDA Unified Registration and Listing System. It is a system created by the FDA to help applicants register through an online system and make electronic submissions. With FURLs, you can view and edit your applications even after submission. Registration and listing information is submitted to the FDA by using

FDA Establishment Registration

Medical Device Facility FDA Establishment Registration

Register your Medical Device Establishments through the FDA’s Unified Registration and Listing System (FURLS)! Things you need to know include:

As an owner or operator, having a valid login ID and password to access the FURLS is a must

As an owner or operator, you must obtain an annual registration

FDA establishment registration

In case of official correspondent, owner or operators must create a separate sub-account for any communication

FDA has established FURLS to advance electronic submissions

Medical Device FDA Establishment Registration

Please complete the form below for Medical Device Facility Registration and FURLS Listing. We will respond to you soon.

Select all applicable Services
Select countries of interest
0/5 (0 Reviews)
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.