US agent, FDA registration, US importer, consulting FDA 510(k), consulenza FDA, certificazione FDA

Overview

ISOplan provides US Importer service, as strictly required by FDA.

Foreign 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.

Foreign manufacturers

Foreign 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 Importers

The 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.