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Prepare Your Medical Device Registration for FY 2027

All currently registered medical device establishments must renew their FDA registration between October 1 and December 31 to remain compliant and legally market devices in the U.S.

New establishments must register within 30 days of beginning operations. 

BEFORE YOU FILE
Fee payment does not resolve inaccurate records or missing information. Early review creates time to identify and correct potential gaps.

  • Establishment Information
  • Device Listings
  • Classification and Labels
  • UDI and GUDID Data
  • Supporting Documentation

Registrar Corp can help identify requirements, organize information, resolve filing questions, and manage ongoing FDA compliance responsibilities.

Request Your Readiness Review

FDA 2027 Registration Period Opens October 1st

The FDA has announced the medical device user fee rates for fiscal year 2027. The rates reflect a 9.9% increase for most standard submission fees and a 20.7% increase for the annual establishment registration fee.

Companies must pay the application fee at the time of submission to avoid delays in review. Any changes to registration or device listing information must be reported within 30 days of the change.

Failing to renew registration can result in: 

  • Suspension of registration in FURLS

  • Cancellation of device listings

  • Shipment holds at U.S. Customs

  • Potential Warning Letters or Import Alerts

  • Delays or rejection of regulatory submissions such as 510(k)s or PMAs

Noncompliance can halt operations and prevent devices from entering the U.S. market. Maintaining timely and accurate registration ensures uninterrupted access to the U.S. market and compliance with FDA regulations.

Leading Medical Device Clients Trust Us

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The Most Experienced in the Industry
With decades of expertise navigating the FDA’s regulatory landscape, we provide a proven track record of success for medical device manufacturers

Save Time, Avoid Penalties
We ensure your registrations, listings, and filings are accurate and submitted on time, so you can focus on innovation and manufacturing.

Comprehensive Compliance Support

Registrar Corp is your trusted partner for navigating FDA Medical Device regulations. With expert services, 24/7 support, and cutting-edge tools, we take the complexity out of compliance and let you focus on what you do best.

FDA Medical Device Registration Management and Listing Assistance
Navigating FDA registration requirements can be complex, but Registrar Corp makes it simple. If your company produces or distributes medical devices in the U.S., annual registration is mandatory. Firms involved in manufacturing, packaging, labeling, or reprocessing must also pay an annual fee. Registrar Corp ensures your registration and device listings are accurate and compliant, saving you time and avoiding costly errors.

Official US Agent Services
Having a U.S. Agent is required for Non-U.S. Medical Device Establishments, but having an expert, professional U.S. Agent is critical. Registrar Corp acts as your reliable communication link with the FDA, receiving inspection notices and important updates on your behalf. Available 24/7, our team specializes in FDA Medical Device regulations, ensuring you’re always prepared to address FDA inquiries quickly and effectively.

Official Correspondent
Managing FDA communication and annual registrations can be overwhelming. Registrar Corp takes the stress off your plate by acting as your Official Correspondent. We handle everything from new registrations and updates to deactivations, ensuring your devices meet compliance standards year-round.

UDI Compliance Made Easy
Registrar Corp helps you navigate the complex world of Unique Device Identification (UDI). Most devices sold in the U.S. must include a UDI on their labels, but understanding and implementing these requirements isn’t always straightforward. Our experts ensure your devices are properly labeled and compliant with FDA regulations.

GUDID Set-Up and Submission
Submitting Unique Device Identifiers (UDI) to the FDA’s Global Unique Device Identification Database (GUDID) is mandatory. Registrar Corp simplifies this process, ensuring your devices are accurately identified from manufacturing through patient use. Leave the technical details to us and stay focused on your business.

FDA Device Classification Support

Regulatory classification is key to selling medical devices in the U.S. With over 1,700 device types spread across 16 medical specialties (i.e., panels), understanding whether your device is Class I, II, or III can be challenging. Registrar Corp’s team of experts provides clear guidance, ensuring your device is classified correctly and meets all necessary controls for safety and effectiveness.

eMDR Compliance Assistance
Submitting adverse event reports electronically is a requirement for medical device manufacturers and importers. Don’t let reporting errors delay your operations. Registrar Corp helps you meet FDA’s electronic Medical Device Reporting (eMDR) standards, protecting your business and keeping you compliant.

ComplyHub Self-Monitoring Platform
Registrar Corp’s advanced ComplyHub platform leverages AI technology and supplier shipping records to automate monitoring and document management. Avoid supply chain disruptions and keep your operations running smoothly with this powerful tool, designed to make compliance easier than ever.

FDA Detention Resolution
If the FDA detains your shipment, Registrar Corp is here to help. Whether it’s due to adulteration, misbranding, or other compliance issues, we work quickly to identify the problem and resolve it. Our team ensures your shipment clears FDA scrutiny as fast as possible, minimizing delays and protecting your bottom line.

Online Compliance Training
Get certified in FDA and ISO 13485 standards with training that keeps you compliant at every stage of the device lifecycle to ensure safety and market readiness. View Catalog.