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U.S. Establishment Registration

US FDA Establishment Registration is a mandatory step for any company that manufactures, repackages, relabels, or imports medical devices into the United States. Medical device manufacturers, repackages, relabels, and importers must register their facilities with the U.S. Food and Drug Administration (FDA) through the FURLS (FDA Unified Registration and Listing System). Whether you operate domestically or internationally, device establishment registration forms the foundation of your legal entry into the U.S. medical device market. Without it, your products cannot be distributed, sold, or imported into the United States.

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Why Must You Register Your
Establishment with the FDA?

Legal background

Proper registration ensures your company appears in the FDA database, confirming your authorization to operate in the U.S. Being fully registered and up to date with FDA requirements is essential for market access and credibility with U.S. partners.

Failure to register your establishment can result in:

- Delays or refusals at U.S. customs
- Import detentions or rejections
- Regulatory sanctions and warning letters
- Inability to market or distribute your products in the U.S.

Our services

How Obelis Helps You Register Your Facility with the FDA

When appointed as your Official FDA Correspondent, Obelis manages the full US FDA Establishment Registration process from start to finish, ensuring compliance and minimizing administrative burdens. Our services include:

Initial facility registration in the FDA’s FURLS system.
Annual renewal management to maintain active status.
Monitoring for FDA updates that could affect your registration.
Acting as your direct communication channel with the FDA.

With Obelis, you gain a proactive partner who ensures your facility remains compliant, your registration is up to date, and your market access is never at risk.

FAQ

Frequently Asked Questions

Who needs to complete US FDA Establishment Registration?

Any company that manufactures, repackages, relabels, or imports medical devices into the U.S. must complete US FDA Establishment Registration. This applies to both domestic and foreign facilities, ensuring they are authorized to operate in the U.S. market.

How often must I renew my US FDA Establishment Registration?

US FDA Establishment Registration must be renewed annually, even if no changes have occurred. Any updates to your facility details or business operations must be reported promptly to maintain compliance.

How can I check if my facility is registered with the FDA?

You can verify your facility’s US FDA Establishment Registration status by searching the FDA’s Establishment Registration & Device Listing database. If you work with Obelis, we handle verification and ensure your registration remains active and accurate.

How can Obelis assist with US FDA Establishment Registration?

As your Official FDA Correspondent, Obelis manages the entire Establishment Registration process, including initial submission, annual renewals, and direct communication with the FDA. We help you avoid delays, ensure compliance, and streamline your market entry into the U.S.