Medical Devices | Registration & Listing
All medical device establishments that develop device specifications, manufacture, process, pack, assemble, label, and export or import medical devices are required to submit to FDA an electronic Device Establishment Registration. The registering establishment must also individually list all medical devices (device listing) introduced into the U.S. market before distribution (or importation) begins. All foreign device firms are required to register their establishments, identify a U.S. Agent for FDA purposes, and perform device listing for their medical devices before importing medical devices into the United States.
FDAImports.com, LLC performs medical device establishment registration and medical device listing for its clients 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.