Bringing a medical device into the U.S. market offers tremendous potential for manufacturers around the world. But with opportunity comes regulatory responsibility. One of the most overlooked — yet critical — roles in the FDA compliance process is the Initial Importer.

At Willow Glen Consultancy LLC, we help medical device companies meet U.S. FDA regulations efficiently and accurately. This article will explain what an Initial Importer is, why it’s required, and how our dedicated service can help your company enter the U.S. market with confidence.

What Is an Initial Importer?

Under 21 CFR 807.3(g), the FDA defines the Initial Importer as “any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale to the ultimate user, but does not repackage, relabel, or otherwise change the device or its packaging.”

In simple terms, if your company is located in the U.S. and you import a medical device made overseas for resale or distribution, even without relabeling or modifying it, you are considered an Initial Importer and must comply with FDA requirements.

This designation applies to many companies, including:

• U.S. subsidiaries of foreign manufacturers
• Distributors or resellers importing foreign-made products
• U.S. agents for international suppliers
• Private labelers importing OEM devices

Responsibilities of an FDA Initial Importer

The Initial Importer is not just a logistics partner — it’s a legally accountable party with regulatory responsibilities, including:

• FDA Establishment Registration
  Initial Importers must register their facility with the FDA annually.
• Device Listing
  All devices imported into the U.S. must be listed with the FDA, and the Initial Importer must ensure this is done correctly.
• Medical Device Reporting (MDR)
  If there are adverse events or complaints, the Initial Importer may be required to file Medical Device Reports with the FDA.
• Complaint Handling Procedures
  An Initial Importer must maintain a system for handling and evaluating complaints from customers or end users.
• Readiness for FDA Inspection
  Like manufacturers, Initial Importers are subject to FDA inspections and must maintain proper documentation.

Many companies underestimate the scope of this role, which can lead to costly delays, refused shipments, and non-compliance penalties.