Registered FDA Initial Importer for Medical Devices
The FDA requires all foreign medical device manufacturers to appoint a registered FDA Initial Importer during device registration. With an office in the United States, QA/RA Consulting Group can further the marketing of your device, from manufacturer to final sale.
Marketing in the United States will often include multiple distributors and sales representatives. Most distributors and sales reps do not want to get involved or register with the FDA.
As Initial Importers, we are subject to FDA inspection and are responsible for reporting adverse events to both you and the FDA.
As your Initial Importer, we will:
Facilitate the marketing of your Class I and/or Class II devices from export 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 an MDR event file for each adverse event.
QA/RA strives to make compliance simple. We also provide US Agent and Official Correspondent Services, learn more here.