The FDA requires all foreign medical device manufacturers to appoint a registered FDA Initial Importer during establishment registration. With an office in the United States, QA/RA Consulting Group 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.
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 your Initial Importer, we are registered with the FDA and can act as a central receiving warehouse that abides by and handles the regulatory requirements outlined in 21 CFR 820. This service allows you, the manufacturer, to freely work with as many distributors as needed without the latter having to register with the FDA.
As Initial Importers, we are subject to FDA inspection and all handling and storage regulations in 21 CFR 820 and are also responsible for reporting and tracking 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; and
Forward received product complaints to you.
At QA/RA Consulting Group, we strive to make compliance simple. Contact us today and ask about our Importing Services or bundling our Official Correspondent, US Agent, and Importer services into one package.