Initial Importer Service

Why Choose RQMIS as Your Initial Importer?

Entering the U.S. medical device market requires strict regulatory compliance with FDA requirements. RQMIS, Inc. serves as your trusted Initial Importer, ensuring your medical products are legally registered and compliant for seamless importation.

With decades of expertise in regulatory compliance, quality assurance, and market access, RQMIS simplifies the process for international manufacturers, reducing regulatory burdens while accelerating time to market.

Our Role as Your Initial Importer

As your Initial Importer, RQMIS acts as the regulatory bridge between your manufacturing operations and the U.S. healthcare system. We assume key responsibilities, including:

FDA Establishment Registration – Register your company with the FDA using our U.S.-based physical address.

Medical Device Listing – Ensure your products are properly listed with the FDA.

Medical Device Reporting (MDR) – Manage adverse event reporting and compliance with five- and 30-day reporting requirements.

Recall & Corrections Management – Assist in FDA-mandated recalls, removals, and corrections.

Customs & Border Protection (CBP) Coordination – Streamline legal importation and manage customs documentation.

Medical Device Tracking – Maintain compliance with 21 CFR Part 821 tracking requirements.

Regulatory & Administrative Support – Up to 8 hours of included administrative support, with additional services available.

Who We Help

Our Initial Importer service is designed for:

International Manufacturers – Medical device, biotech, pharmaceutical, nutraceutical, cosmetic, and food manufacturers entering the U.S. market.

Medical Product Distributors – Companies requiring regulatory compliance support for imports.

Startups & Mid-Sized Companies – Businesses with limited U.S. presence seeking expert regulatory guidance.

Established Medical Companies – Organizations looking for a reliable and experienced Initial Importer partner.

The RQMIS Advantage

Proven Regulatory Expertise – Over 25 years of experience in FDA regulatory compliance.

Streamlined Importation Process – Our team ensures smooth customs clearance and compliance.

Dedicated Client Support – Personalized assistance to navigate complex regulatory landscapes.

Growth-Focused Approach – Helping you expand into the U.S. market while ensuring full compliance.

Ready to Enter the U.S. Market?

Let RQMIS be your trusted Initial Importer partner. We handle the regulatory complexities, so you can focus on growing your business.