Initial Importer & U.S. Agent

As defined by the FDA, an initial importer is defined in Code of Federal Regulations as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

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For foreign manufacturers, navigating U.S. regulations can be challenging. We understand the complexities involved in entering a new market, and we are here to assist you every step of the way.

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Key Questions You Might Have:​

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• What is the difference between an initial importer and an importer of record?

• Do we need to ship our products to the initial importer first?

• Will the initial importer assist with Customs and the FDA?

• Is my U.S. Agent or distributor also my initial importer?

• Can a hospital act as the initial importer?

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These are common questions, and we are here to provide clarity.

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Essential Requirements

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By law, an initial importer must be a domestic establishment with a physical address in the United States. This location must be staffed by individuals responsible for ensuring compliance with all applicable FDA laws and regulations. The FDA requires this U.S. establishment to be accountable for reporting adverse events, recalls, and customer complaints.

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Additionally, the initial importer must register with the FDA and pay the annual registration fee, similar to the manufacturer. This ensures that there is a responsible party within the U.S. to manage compliance and reporting obligations.

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Our Commitment: We are dedicated to helping you understand and meet these requirements, ensuring a smooth entry into the U.S. market. Our expertise will guide you through the regulatory landscape, making the process as seamless as possible.