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.