The FDA requires all medical device manufacturers with no office within the United States to appoint a registered FDA Initial Importer. With an office in the United States, your initial importer can further the marketing of your device, from manufacturer to final sale, but does not repackage or change the container, wrapper, or labeling of the device. Importers are also responsible for reporting and tracking adverse events to both the manufacturer and the FDA.
Our Services Include...
Facilitate the marketing of devices (Class I, II) from a foreign manufacturer to the person who makes final delivery or sale
Report adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking (if applicable)
Maintain MDR event file for each adverse event
Forward received product complaints to manufacturer