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 medical devices or offering medical devices for export to the United States, must identify all known U.S. importers of these devices.
If your medical devices are being shipped to any Amazon U.S. warehouse, click here.
§ 807.3 Definitions.
(g) Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
(x) Importer means, for purposes of this part, a company or individual in the United States that is an owner, consignee, or recipient, even if not the initial owner, consignee, or recipient, of the foreign establishment’s device that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or uses the device, unless the foreign establishment ships the device directly to the consumer or patient.
(y) Person who imports or offers for import means, for purposes of this part, an agent, broker, or other entity, other than a carrier, that the foreign establishment uses to facilitate the import of its device into the United States.
The 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:
● Designate a U.S. Agent.
● Medical Device Listing.
● Quality System.
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.
● Premarket Notification 510(k), unless exempt, or Premarket Approval.
● Labeling.
● Medical Device Reporting.
● Medical Device Tracking, where applicable.
A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting.
Patients who received a tracked device may refuse to release, or refuse permission to release their name, address, social security number, or other identifying information for the purpose of tracking.
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.
An entry for a regulated product that is filed with U.S. Customs and Border Protection (CBP), will also be electronically submitted to FDA for review. An importer or customs broker must submit required entry information to CBP through the Automated Commercial Environment (ACE) system.
The required entry information includes:
▪ Country of origin
▪ FDA product code
▪ Product description
▪ Name of manufacturer
▪ Name of shipper
▪ Affirmations of compliance codes
▪ Harmonized Tariff Schedule (HTS) code
Make sure to have your DUNS Number as well as product details.
▪ DUNS Number (All companies, starting with the Manufacturer).
▪ Registration Number (FDA Establishment Identifier or FEI).
▪ Owner/Operator Number.
▪ Device Listing Number.
▪ Premarket Submission Number.
▪ Product Code.
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