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. Dawa Medical answers on weekends and during US holidays, when you are most likely to need help. Most initial importers will not. We are willing to make that commitment because we understand the importance of addressing our clients’ immediate concerns. Dawa Medical will help you through the importation process and make clear what Customs and the FDA require, so that entries go smoothly. 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 a Customs matter. Two totally separate things. Note also that 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.
Frequently Asked Questions
Is my distributor also my initial importer?
Not automatically. Your distributor is only your initial importer if they are separately registered with the FDA as one and are named as such at entry. Most distributors are not, and most do not want to be.
Can a hospital act as the initial importer?
Generally no. A hospital that takes final delivery of the device for use is the end user, not an entity furthering the marketing of the device. It would also have to register with the FDA as an initial importer and take on MDR reporting duties, which hospitals do not do.
What is the difference between an initial importer and an importer of record?
The initial importer is an FDA requirement covering post-market responsibility such as adverse event reporting, complaints, recalls and device tracking. The importer of record is a US Customs and Border Protection requirement covering the entry itself: duties, tariffs, valuation and classification. One company can hold both roles but they are separate designations filed with separate agencies.
Do I need to ship my products to the initial importer first?
No. The initial importer is a regulatory designation, not necessarily a physical stop. Product can ship directly to your distributor or customer while Dawa Medical holds the initial importer role.
What happens if I import without a registered initial importer?
The shipment will be held. Fees accrue while it sits, the FDA will not release the goods for distribution, and the agency may issue a Notice of Action. Submitting an incorrect initial importer at entry is one of the most common device entry errors.
How much does an FDA initial importer cost?
The FDA annual establishment registration fee is $11,423 for FY 2026. Using Dawa Medical as your initial importer means you do not pay that fee separately for an importer establishment.
