Medical Devices | Registration & Listing
Medical device establishments that develop device specifications, manufacture, process, pack, assemble, label, and export or import medical devices must register with FDA. The registering establishment must also list all medical devices (device listing) introduced into the U.S. market before distribution (or importation) begins. In addition, foreign device establishments must register their establishments, identify a U.S. Agent for FDA purposes, and lists their devices before importing them into the United States.
FDAImports.com, LLC performs medical device establishment registration and medical device listings for clients from around the world. However, the medical device registration and listing requirements are only the first step. FDAImports.com, LLC also helps its clients with all substantive medical device labeling regulations, medical device classifications, preparation and filing of Pre-Market Notifications (PMNs) or 510(k)s, and interacts with FDA on their clients’ behalf to ensure the FDA is satisfied that medical device regulatory compliance is in place. Although medical device registration and listing might represent the door to the U.S. Market, FDAImports.com, LLC helps medical device companies find The Way Through the door, across the border, and into the U.S. market.