Initial Importer Service

Enter the U.S. Market—Without Regulatory Roadblocks

Bringing a medical device into the United States isn’t just about logistics—it’s about meeting strict FDA regulatory requirements from day one.

Without the right structure in place, companies face:

• Shipment delays or refusals at the border
• FDA compliance issues
• Costly disruptions to market entry

RQMIS serves as your trusted Initial Importer, ensuring your products are properly registered, compliant, and ready for seamless entry into the U.S. market.

What Is an Initial Importer?

An Initial Importer is the U.S.-based entity responsible for ensuring imported medical devices comply with FDA regulations.

This includes:

• Verifying manufacturer registration and device listing
• Maintaining required records
• Supporting complaint handling and reporting obligations
• Ensuring traceability and regulatory accountability

Without a compliant Initial Importer, your product cannot legally enter the U.S. market.

The RQMIS Advantage

With decades of experience in regulatory compliance, quality systems, and market access, RQMIS goes beyond basic importer requirements.

We provide a fully integrated approach that reduces regulatory risk while accelerating your path to market.

What We Deliver

FDA Registration & Device Listing Support

We ensure your products are properly registered and listed with the FDA before importation—eliminating delays and compliance gaps.

Importer Compliance & Recordkeeping

We fulfill all Initial Importer obligations, including:

• Maintaining required FDA records
• Ensuring traceability of imported devices
• Supporting inspection readiness

Complaint Handling & Adverse Event Support

As part of your compliance framework, we help manage:

• Complaint intake and documentation
• Adverse event identification and reporting (MDR)
• Integration with your post-market surveillance system

U.S. Market Entry Strategy

We don’t just help you import—we help you succeed.

• Alignment with your regulatory pathway
• Coordination with your quality system (QMS)
• Support for long-term compliance and growth

Built for International Manufacturers

RQMIS simplifies U.S. market entry by acting as your local regulatory partner.

We help you:

• Navigate FDA requirements with confidence
• Reduce internal regulatory burden
• Avoid costly delays at customs or during inspections
• Scale your U.S. operations efficiently

The Outcome

With RQMIS as your Initial Importer, you can:

• Achieve compliant, hassle-free product importation
• Accelerate entry into the U.S. market
• Reduce regulatory risk and operational complexity
• Maintain ongoing FDA compliance

Don’t Let Import Requirements Slow You Down

Entering the U.S. market is a major opportunity—but only if done correctly.