Initial Importer & U.S. Agent
Understanding the Role of an Initial Importer in U.S. Market
What is an Initial Importer?
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.
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.
Key Questions You Might Have:
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What is the difference between an initial importer and an importer of record?
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Do we need to ship our products to the initial importer first?
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Will the initial importer assist with Customs and the FDA?
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Is my U.S. Agent or distributor also my initial importer?
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Can a hospital act as the initial importer?
These are common questions, and we are here to provide clarity.
Essential Requirements
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.
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.
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.
FDA U.S. Agent
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process.
Each foreign establishment may designate only one U.S. agent.
The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
U.S. Agent FDA requirements:
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Assisting FDA in communications with the foreign establishment.
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Responding to questions concerning the foreign establishments devices that are imported or offered for import into the United States.
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Assisting FDA in scheduling inspections of the foreign establishment.
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If the FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
PLEASE NOTE THAT THE U.S. AGENT HAS NO RESPONSIBILITY RELATED TO REPORTING OF ADVERSE EVENTS UNDER THE MEDICAL DEVICE REPORTING REGULATION (21 CFR PART 803) OR SUBMITTING 510(K) PREMARKET NOTIFICATIONS (21 CFR PART 807, SUBPART E).