FDA 2026 Medical Device Establishment Registration Renewal: Complete Guide for Manufacturers and Importers
- SANRUBIO, LLC
- 5 days ago
- 5 min read
The U.S. Food and Drug Administration (FDA) mandates that all medical device establishments, whether based in the United States or exporting from countries like Mexico, Colombia, Argentina, or Brazil, renew their registration annually for the 2026 fiscal year.
Governed by 21 CFR Part 807, this process is mandatory for manufacturers, initial importers, specification developers, and distributors marketing medical devices in the U.S. market. The renewal must be completed between October 1, 2025, and December 31, 2025, to avoid suspension of registration and Device Listing.
In Latin America, where the medical device market is expanding rapidly (e.g., Mexico reported a 15% increase in medical device exports in 2024 per CANIFARMA), timely FDA renewal is critical to maintaining competitiveness in the U.S. Sanrubio, LLC, experts in FDA compliance, supports companies in the U.S., Latin America, Europe and Asia to ensure an error-free renewal process, particularly for manufacturers in Latin America (Mexico, Colombia, Argentina, and Brazil), as well as in Europe and Asia.
1. What is FDA Medical Device Establishment Registration Renewal?
The FDA Medical Device Establishment Registration Renewal is an annual requirement for all manufacturers, specification developers, initial importers, and distributors of medical devices operating in the U.S. market, whether based in the U.S. or in Latin America (Mexico, Colombia, Argentina, and Brazil), as well as in Europe or Asia.
Regulated under 21 CFR 807.20, this process confirms that a company remains active and compliant through the FURLS/DRLM system (FDA Unified Registration and Listing System).
For foreign manufacturers in Latin America, such as those in Mexico (exporting over $2 billion in medical devices per COFEPRIS) or Brazil (regulated by ANVISA), maintaining an active U.S. Agent is mandatory under 21 CFR 807.40 to complete the renewal.
Sanrubio, LLC, provides expert support for U.S., Latin American, European, and Asian companies, ensuring compliance with this critical requirement.
2. Who needs to renew in 2026?
The following establishments must renew their FDA registration for the 2026 fiscal year:
Manufacturers of Class I, II, and III medical devices.
Contract manufacturers and specification developers.
Initial importers
Repackers and relabelers.
Foreign manufacturers exporting to the U.S., including in Latin America (Mexico, Colombia, Argentina, and Brazil), as well as in Europe and Asia.
Establishments registered under a 510(k), PMA, De Novo, or exemptions.
3. Key dates for FDA renewal 2026
Start Date: October 1, 2025
Deadline: December 31, 2025
Fiscal Year: 2026
The legal basis is found in 21 CFR 807.21 and FD&C Act Section 738. Renewals are not accepted outside this period, and failure to comply results in automatic suspension of registration and removal of the Device Listing.
Note: in Latin America (Mexico, Colombia, Argentina, and Brazil), as well as in Europe and Asia, where customs regulations are stringent, missing the renewal deadline can lead to shipment holds by CBP (U.S. Customs and Border Protection).
4. Requirements for completing the renewal
To successfully renew in 2026, you must:
Maintain an active Owner/Operator number in FURLS.
Update establishment details (address, contacts).
Confirm devices listed in the DRLM system.
Designate a valid Official Correspondent.
Pay the Annual Establishment Registration Fee.
Foreign manufacturers: Ensure an active U.S. Agent
The process is conducted exclusively through the FDA Industry Systems (FIS). Partial renewals or submissions via email or mail are not accepted.
5. Common mistakes leading to FDA suspensions
Avoid these frequent errors to prevent registration suspension:
Failure to pay the Annual Establishment Registration Fee.
Not verifying the status of listed devices in DRLM.
Maintaining an inactive U.S. Agent (critical for foreign manufacturers).
Failing to update establishment information.
Declaring incorrect activities (e.g., registering as a manufacturer instead of a distributor).
Missing the December 31, 2025, deadline.
6. Step-by-Step process for 2026 renewal
Log into your FURLS account.
Verify Owner/Operator information.
Update establishment details (address, contacts).
Validate devices in the Device Listing system.
Confirm the U.S. Agent (mandatory forforeign manufacturers).
Generate and pay the Annual Registration Fee.
Complete the renewal form in FIS.
Download the renewal confirmation.
Sanrubio, LLC offers personalized support for companies in the U.S., in Latin America (Mexico, Colombia, Argentina, and Brazil), as well as in Europe and Asia, to ensure a seamless process.
7. FDA fees and costs for 2026
The FDA publishes annual registration fees under MDUFA, for 2026, October 1, 2025, through September 30, 2026 the Annual Establishment Registration Fee is: $11,423
8. Consequences of missing the renewal deadline
Failing to renew by December 31, 2025, results in:
Immediate suspension of registration in FURLS.
Cancellation of the Device Listing.
Prohibition from marketing devices in the U.S.
Shipment holds at customs by CBP.
Risk of receiving a Warning Letter or Import Alert.
9. Comparison: U.S. vs. Foreign Manufacturers
Aspect | U.S. Companies | Latin American Manufacturers |
U.S. Agent | Not required | Mandatory and active |
Annual Fee Payment | Mandatory | Mandatory |
Renewal Period | Oct 1 - Dec 31 | Oct 1 - Dec 31 |
Device Listing | Confirm listing | Confirm listing |
Suspension Risk | If not renewed | If not renewed + inactive U.S. Agent |
10. Frequently Asked Questions about FDA renewal 2026
When should I renew my FDA registration in 2026? Between October 1 and December 31, 2025.
Does the FDA send renewal reminders? No, it’s the establishment’s responsibility to meet deadlines.
Is a U.S. Agent required for manufacturers in Mexico or Brazil? Yes, all foreign manufacturers must have an active U.S. Agent.
What happens if I miss the payment deadline? Your registration will be suspended, and you cannot market devices in the U.S.
How does Sanrubio, LLC support companies? We assist with U.S. Agent services, FURLS updates, and error-free renewals.
11. Ensure Compliance with Sanrubio, LLC
The FDA registration renewal for 2026 is a mandatory and technical process for manufacturers in the U.S., Latin America, Europe and Asia. Meeting deadlines, fulfilling requirements, and maintaining an active U.S. Agent (for Mexico, Colombia, Argentina, Brazil, etc.) ensures uninterrupted access to the U.S. market. With the medical device industry growing in Latin America (e.g., Brazil exported $500 million in devices in 2024 per ABIMO), avoiding suspensions is critical for competitiveness.
Sanrubio, LLC, with expertise in the U.S., Latin America, Europe and Asia, helps you navigate this process effortlessly. From U.S. Agent management to FURLS renewals, we ensure compliance so you can focus on your business.
At Sanrubio, LLC, we offer:
Medical Device Establishment Registration Renewal
Personalized regulatory advice: from Pre-Submission design to 510(k) submission (Pre-market notification), De Novo or Breakthrough Devices submission.
Strategic location: in Miami, key hub for foreign manufacturers entering the U.S. market.
Free initial consultancy: analyze your case with us and optimize your regulatory strategy.
Ready to bring your Medical Devices to the U.S. market?
Contact us for a free personalized consult and move ahead with confidence in your regulatory journey.
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