The FDA requires all foreign medical device manufacturers to appoint a registered FDA Initial Importer during device registration. QA/RA Consulting Group, Inc. provides US Initial Importer services for foreign establishments seeking to import medical devices into the United States. 

 

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 ($7,653 in FY 2024). 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 your company.

 
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?

​

"My name is Scott Bednar.  As the CEO and a Principal Consultant at QA/RA Consulting Group, Inc., I personally handle all international Initial Importer, U.S. Agent, and Official Correspondent clients.  With 33 years of Quality and Regulatory experience, you can be assured that your international dealings with FDA will be handled in the best possible manner.  Your account will not be handed off to a junior consultant or associate once the contract is signed.  As a client, you will have direct access to me 24/7.  I have been acting as an Initial Importer since 2014 and have experience with all facets of the importation process.  We also have established relationships with the best 3PL, transportation, and customs brokers.  

Please let us know you are interested in our services by submitting an Initial Importer Inquiry on this page.  We would be delighted to discuss how we can assist you in your U.S. marketing endeavor."

​

Sincerely,

Scott A. Bednar

CEO/Principal
 

 

QA/RA strives to make compliance simple. We also provide US Agent and Official Correspondent Services, learn more here.