The Initial Importer must be staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
An Initial Importer is not an Importer of Record, but could be both.
Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
An initial importer is any individual or company that furthers the marketing of a device from a foreign manufacturer to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
An initial importer of a medical device is required to comply with the following regulatory requirements:
■ Establishment registration
■ Medical Device Reporting (MDR). Importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions
■ Reports of Corrections and Removals
■ Medical Device Tracking, where applicable, because certain devices must be tracked through the distribution chain.
Before import takes place, foreign manufacturers must meet applicable U.S. regulations
- Establishment registration
- Medical Device Listing
- Quality System
- Premarket Notification 510(k), unless exempt, or Premarket Approval
- Medical Device Reporting
- A radiation-emitting electronic product that is also a medical device must meet the Electronic Product Radiation Control (performance standards, labeling, and submission of radiation safety product reports). A foreign manufacturer submits a radiation safety product report to FDA for review. Upon receipt, FDA assigns the report an accession number. An accession number is a unique identifier for the product safety report maintained in an FDA database. An importer may submit a radiation safety product report on behalf of a foreign manufacturer.
- Designate a U.S. Agent
All medical devices imported into the United States must meet the regulatory requirements of both the U.S. Customs and Border Protection (CBP) and FDA. Products that do not meet FDA regulatory requirements may be detained upon entry.
Ready to import, but unable to comply with multiple regulatory requirements?
ITB HOLDINGS LLC could be your INITIAL IMPORTER, while your company remains the IMPORTER of RECORD responsible for all customs duties and other clearance related fees.
Contact us, seven days a week, for additional information.