U.S. Agent vs. Initial Importer: A Critical Choice for FDA Import Success

Medical Device Global Market Access · Sep 21, 2025 · 2m

This episode demystifies the distinct and critical roles of the FDA U.S. Agent and the Initial Importer for medical device manufacturers entering the U.S. market. We explore the specific regulatory responsibilities of each, highlighting why appointing a distributor without proven compliance expertise can jeopardize your import success and post-market standing. • What is the fundamental difference between an FDA U.S. Agent and an Initial Importer? • Who is legally responsible for reporting adverse device events to the FDA? • Can your distributor also act as your Initial Importer? • What are…