Achieve FDA Medical Device Compliance
with Confidence
Registrar Corp simplifies FDA regulations for medical device manufacturers with unmatched expertise. We are your trusted partner assisting in achieving compliance, avoiding costly delays, and reaching the US market faster.
Comprehensive Services
We help companies properly comply with US FDA Medical Device requirements including:
- Registration Management & Device Listing: Handle mandatory FDA filings effortlessly.
- Official US Agent: Represent your business with US-based operational requirements
- UDI / GUDID Set-Up & Submissions: Simplify unique device identification and database submissions
- Device Classification Support: Accurately determine the FDA Class for your medical device
- eMDR Service: Streamline electronic medical device reporting
- Detention Assistance: Resolve compliance holds effectively
- ComplyHub Self-monitoring: Assure your regulatory compliance with ease
- Online Compliance Training: Empower your team with up-to-date compliance education
U.S. FDA Medical Device Registration
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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.
Leading Medical Device Companies Use Registrar Corp
Product and Service Details
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.
Transparent & Flexible Plans
Choose the package that fits your needs:
Registration Management
Official U.S. Agent
Device Classification
eMDR Service
Detention Assistance
ComplyHub Self-Monitoring
UDI/GUDID Set-up
Device Listing
GUDID Submissions
Online Training (Not in Packages. ADD ON only)
Essentials
Available
in Blocks
Add-on option
with Reg Pro
Standard
Available
in Blocks
Add-on option
with Reg Pro
Professional
1 Device Included
Available
in Blocks
Add-on option
with Reg Pro
Frequently Asked Questions
FDA Medical Device Registration is a mandatory annual process for companies that produce or distribute medical devices in the U.S. It ensures that firms comply with FDA regulations to legally market their devices.
Companies involved in manufacturing, packaging, labeling, or reprocessing medical devices in the U.S. must pay an annual registration fee.
Registrar Corp ensures accurate and compliant FDA registration and device listings, saving you time and minimizing costly errors.
The FDA requires Non-U.S. Medical Device Establishments to appoint a U.S. Agent as a communication link for inspection notices and updates. Registrar Corp provides 24/7 support as your professional U.S. Agent.
An Official Correspondent manages FDA communications, annual registrations, and updates. Registrar Corp handles these responsibilities, ensuring devices meet compliance standards year-round.
Unique Device Identification (UDI) is required on most medical device labels in the U.S. Registrar Corp ensures your devices are properly labeled and meet FDA’s UDI requirements.
The Global Unique Device Identification Database (GUDID) is where UDIs are submitted to the FDA. Registrar Corp simplifies the process of GUDID set-up and submission for accurate device identification.
Registrar Corp provides expert guidance to help classify your device as Class I, II, or III, ensuring it meets the necessary safety and effectiveness controls.
Electronic Medical Device Reporting (eMDR) is required for manufacturers and importers to submit adverse event reports electronically. Registrar Corp ensures compliance with eMDR standards to avoid reporting errors.
ComplyHub is Registrar Corp’s AI-powered self-monitoring platform that automates compliance monitoring and document management, helping avoid supply chain disruptions.
Registrar Corp is the global leader in FDA compliance and provides expert guidance, 24/7 support, and advanced tools to simplify your regulatory requirements, allowing you to focus on your business while we handle the complexities.
If your shipment is detained due to compliance issues, Registrar Corp works quickly to identify the problem and resolve it, minimizing delays and ensuring your shipment clears FDA scrutiny.
Start Your FDA
Compliance Journey Today
Partner with the industry’s foremost expert to confidently navigate FDA regulations and bring your medical device to the US market without hassle.