Skip to main content


An initial importer is the entity who guarantees that the products or services imported meet regulatory requirements, ensuring a facilitated import process of products. These requirements include, but are not limited to:
  • Establishment must be registered with the FDA
  • Establishment must have a physical address in the United States, as well as a staffed by responsible individuals to ensure the compliance of all FDA laws and regulations.
  • Responsible for registering, reporting, and archiving all non-conformities, customer complaints, recalls and all post-market survey activities.
  • Responsible for Medical Device Tracking of certain devices through the supply chain.

Don't make the mistake to confuse US Agent or distributor with the Initial Importer role.

Contact Us
Initial Importer