An Initial Importer is the entity responsible for ensuring that imported medical devices and healthcare products comply with FDA regulations, helping facilitate a smooth and compliant import process into the United States. Key requirements include, but are not limited to:
- The establishment must be registered with the FDA.
- The establishment must maintain a physical address in the United States and be staffed by responsible individuals who ensure compliance with all FDA laws and regulatory requirements.
- Responsible for registering, reporting, and maintaining records of non-conformities, customer complaints, recalls, and post-market surveillance activities.
- Responsible for Medical Device Tracking for certain devices throughout the supply chain.
Don't make the mistake to confuse US Agent or distributor with the Initial Importer role.
