QA/RA offers US Initial Importer services to foreign establishments aiming to bring medical devices into the United States. To import a medical device, an FDA-registered US Initial Importer is necessary. Without this, you will encounter problems during the import process. The shipment will be put on HOLD, and fees will accrue until an Initial Importer is designated. We can help!
What is a US Initial Importer?
Under FDA regulations, 21 CFR § 807.3(g), an Initial Importer is defined as "any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package."
Under § 807.40(a), Initial Importers must register with the FDA and pay the annual registration fee ($9,280 in FY 2025). The Initial Importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations. More information on who must register their establishment, list their devices, and pay the user fees can be found here.
Device Initial Importers have responsibilities under 21 CFR § 803 Medical Device Reporting, § 806 Reports of Corrections and Removals, and, in some cases, § 821 Medical Device Tracking.
Why is a US Initial Importer Required?
Without a FDA-registered US Initial Importer, the FDA will not release your goods for distribution into the United States and may issue a Notice of Action against you.
The submission of incorrect information related to the device Initial Importer is a common entry error occurring during the medical device import process. Refer to the FDA website to see common entry errors. According the the FDA, "Submitting the incorrect device initial importer could result in either the distribution of products into U.S. commerce that may not meet the FDA's laws and regulations or the shipment being unnecessarily held for additional review." Many times, foreign establishments identify an importer of record, but not an FDA-registered Initial Importer, resulting in delays and/or noncompliance.
Why Should You Choose QA/RA?
QA/RA is a full-service FDA consulting firm staffed with quality, regulatory, compliance, and legal experts. We are committed to providing higher levels of service at affordable rates. Partnering with us ensures you will always be able to reach someone equipped to address your questions in a timely fashion.