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!