FDA Requirements

As per FDA definition, an initial importer is 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. 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.

That definition may be obscure for many, especially if you are not familiar with regulations in the United States. We understand the incredible challenge and the amount of work it takes to enter a new market, and we are here to help.  

You are probably asking yourselves: is my distributor also my initial importer? Can the hospital act as the initial importer? What is the difference between an initial importer and an importer of record? Do we need to ship our products to the initial importer first? Will the initial importer help me deal with Customs and the Food and Drug Administration (FDA)? These are all great questions that people are oftentimes unable to discern.

By law, an initial importer is required to be a domestic establishment with a physical address. It needs to be a place of business that the FDA can visit and inspect. An initial importer also needs to register with the FDA and pay the annual registration fee (same goes for the manufacturer). The reason for these requirements is that the FDA wants a US establishment to be responsible for reporting adverse events, recalls and customer complaints. In fact, this is the main responsibility of the initial importer…reporting!

The manufacturer still has a set of obligations under §807.40 and §807.41.  For example:

Establishment Registration

Device Listing

Follow Guidance Under The GMP

Identify One Us Agent

For a foreign manufacturer, it can become a real struggle to find distributors that are registered with the FDA as an initial importer.

Even if you do, they will probably not cover all regions of the USA.  Most distributors or 1099 agents do not want to manage those responsibilities, pay the annual registration fee, and build SOPs. The ideal solution is to identify an independent company that specializes in serving the role as an initial importer. Fortunately, that is exactly what we at Dawa Medical have years of experience in.

Dawa Medical is not just another initial importer; we are your partner throughout every step of the process. Unlike Dawa Medical, most initial importers will not be there for you on weekends or during US holidays when you may need their assistance most. We are willing to make these sacrifices because we understand the importance of addressing our client’s immediate concerns. We are going be there to help you with the importation process and assist you in understanding what is required by Customs and the FDA so that things will go smoothy. Finally, there is a lot of confusion between the role of the initial importer and the importer of record. The initial importer is an FDA requirement, whereas the importer of record is related to Customs – 2 totally separate entities! Also, in case you are not aware, the importer of record is always the shipper when you ship DDP.

Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as to report certain malfunctions.

  • The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and non MDR events) must be forwarded to the manufacturer.
  • Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain. 

In choosing your initial importer, you will need to make sure that they can provide you with their standard operating procedures (SOPs) for their role as an initial importer and that they are conforming with regulatory requirements.  The initial importer must conform with specific procedures regarding the 21CFR 820.  The initial importer is also subject to:

Medical Device Reporting

Medical device reporting (MDR) under 21 CFR 803.40 and 21 CFR 803.42

Reports of Corrections

Reports of corrections and removal under 21 CFR 806

Medical Tracking

Medical Tracking under 21 CFR (if applicable)

Your success is our success!

Dawa Medical LLC is your one stop shop for all your business needs to expand into the lucrative US medical device market. We are here to be your business partner and to create a successful future for your company.