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.
Visit FDA website
Don't make the mistake of confusing a US Agent or distributor with the Initial Importer role.
Initial Importer