provides US Importer service, as strictly required by FDA.
firms that manufacture medical devices and/or products that emit
radiation that are imported into the United States must comply with
applicable U.S. regulations before, during, and after importing into
the U.S. or its territories. In order to import medical devices and/or
products that emit radiation into the U.S., the product must meet FDA
regulatory requirements. FDA does not recognize regulatory approvals
from other countries. The following is a summary of FDA requirements
for medical devices and products that emit radiation.
manufacturers must meet applicable United States (U..S.) medical device
regulations in order to import devices into the U.S. even if the
product is authorized for marketing in another country. These
requirements include registration of establishment, listing of devices,
manufacturing in accordance with the quality system regulation, medical
device reporting of adverse events, and Premarket Notification 510(k)
or Premarket Approval, if applicable. In addition, the foreign
manufacturers must designate a United States agent. As with domestic
manufacturers, foreign manufacturing sites are subject to FDA
inspection. Information on U.S. regulatory requirements can be found in
the Device Advice section.
initial importer of the device must register its establishment with
FDA. An initial importer is 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. Registration information can
be found under Establishment Registration.
Initial importers are
also subject to Medical Device Reporting (MDR) under 21 CFR 803,
Reports of Corrections and Removals under 21 CFR 806, and Medical
Device Tracking under 21 CFR 821, if applicable. Under the MDR
regulations importers are required to report incidents in which a
device may have caused or contributed to a death or serious injury as
well as report certain malfunctions. The importers must maintain an MDR
event file for each adverse event. All product complaints (MDR and
nonMDR events) must be forwarded to the manufacturer. Under Medical
Device Tracking requirements, certain devices must be tracked through
the distribution chain.