US FDA Establishment Registration and Device Listing

Stay Compliant with FDA Establishment Registration and Listing

In the United States, all businesses involved in the production and distribution of medical devices, drugs, combination products, dietary supplements, or cosmetics are required to register annually with the FDA.

Why is FDA Establishment Registration and Listing Important?

• Regulatory Compliance: Annual registration is mandatory to legally manufacture, distribute, or sell medical products in the U.S. market.
• Avoid Missed Deadlines: Failure to meet registration deadlines can result in lapses in certificates and potential disruptions in your ability to sell products.
• Traceability: The FDA Registration and Listing Database helps identify manufacturing facilities and their products, ensuring better preparedness during public health emergencies.

What’s Required for Medical Device Facilities?

• Establishment Registration: All facilities must register annually with the FDA.
• Device Listing: Manufacturers must list each medical device they produce in the FDA Establishment Registration and Listing Database

How RQMIS Can Help:

How RQMIS Can Help:

• Annual FDA Registration & Listing Support: We handle the tedious administrative tasks, ensuring compliance with all FDA requirements.
• Deadline Management: Stay ahead of deadlines with proactive reminders and efficient execution.
• Expert Guidance: Our experienced consultants simplify the complex FDA registration and listing process, minimizing your workload.
• Global Support: Whether you're based in the U.S. or abroad, we’ll ensure your business meets all FDA requirements.

Don’t risk non-compliance or disruptions in your operations.

Stay Compliant: Renew Your FDA Establishment Registration and Device Listing on Time!

Key Renewal Recommendations:

Renew Before December 1st: We strongly recommend submitting your FDA Establishment Registration and Listing renewal by December 1st to allow ample processing time.
Avoid Delays: Processing times can vary, especially during high-volume renewal periods or unforeseen delays.

How RQMIS Can Help:

• Complete Renewal Management: We handle the entire renewal process for your US FDA Establishment Registration and Medical Device Listing.
• Accurate & Timely Submissions: Our experts ensure all documentation is accurate and submitted on time.
• Continuous Compliance Monitoring: Stay informed about renewal timelines and requirements with proactive updates from our team.
• Support for Global Companies: Whether your business is based in the U.S. or internationally, we’ve got you covered.

Don’t let administrative oversights jeopardize your ability to sell or distribute your medical devices in the U.S.