FDA Device Registration and Listing

FDA Device Registration and Listing Services by I3CGlobal

Navigating the complex process of FDA medical device registration and listing can be challenging, but I3CGlobal makes it simple and efficient. We assist manufacturers, importers, and distributors in registering their medical devices with the U.S. FDA in full compliance with regulatory requirements.

Our expert team handles Establishment Registration, Device Listing, and helps ensure that your documentation meets FDA standards. Whether you're launching a new device or updating an existing listing, I3CGlobal provides accurate, timely, and cost-effective solutions. Partner with I3CGlobal to confidently access the U.S. medical device market and ensure regulatory success.

Transcript

1. USFDA Device Registration and Listing by I3CGLOBAL Overview of Requirements, Processes, and Responsibilities. For detailed information on US FDA Device Registration. CLICK HERE.
2. Introduction to Requirements Purpose Explain FDA registration and listing. Applies To Domestic and foreign manufacturers, reprocessors, etc.
3. Who Must Register and List Domestic & Foreign Establishments marketing devices in U.S. Includes Manufacturers, repackagers, U.S. agents. Contractors Contract manufacturers, specification developers.
4. When to Register and List 1 Initial Registration Within 30 days of marketing. 2 Annual Registration Oct 1 to Dec 31 each year. 3 Updates Within 30 days of changes.
5. How to Register and List Create Account In FDA's FURLS system. Pay Fee Via DFUF system (if applicable). Submit Registration and listing through FURLS.
6. Payment Process 1 Annual Fee Establishment registration fee. 2 No Waivers No reductions or waivers. 3 Online Payment Through FDA User Fee website.
7. U.S. Agents for Foreign Entities Designation Foreign firms must designate a U.S. Agent. Click here to Know more about US FDA Agent Services. Responsibilities • Communication with FDA. • Responding to device questions. • Assisting with inspections.
8. Key Takeaways & Resources Legal Compliance Register and list for U.S. market. Stay Current Annual renewals and timely updates. Resources FDA website, FURLS manual, Device Advice.
9. Thank you Visit our website www.i3cglobal.com