Medical U.S. Agent and Establishment Registration Support

$595.00

To assign Register-FDA as your Medical Establishment US Agent and have our company register your Medical Facility, please complete the following information.

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Description

Medical U.S. Agent and Establishment Registration Support
The U.S. FDA regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Most establishments are required to pay an establishment registration fee to the U.S. FDA. The U.S. FDA establishment registration User Fee for FY 2018 is $4624.

The annual fee for us to serve as your U.S. Agent, Official Correspondent, and Regulatory Contact includes the following:

  • All of the U.S. Agent responsibilities outlined by the FDA
  • One medical device listing
  • Help determining whether registration exclusions apply
  • Preparation and submission with U.S. FDA
  • Make changes, updates and cancellations as needed
  • Assistance with preparing and submitting your payment per U.S. FDA’s requirements
  • Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information