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Fees: Medical Device Registration, U.S. Agent, and Regulatory Contact (Non-U.S. Establishments)

Non-U.S. Medical Device Establishments that are not exempt from U.S. FDA's registration and listing requirements must designate a U.S. Agent and Official Correspondent for U.S. FDA communications. The U.S. Agent's responsibilities are different from those of an agent used for business purposes. Establishments with devices that require Unique Device Identifiers (UDIs) must also designate a Regulatory Contact for UDI purposes.

The fee for Registrar Corp to serve as your U.S. Agent, Official Correspondent, and Regulatory Contact is US$ 795 annually and includes:

  • Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
  • Assistance determining if U.S. FDA Medical Device User Fees 1 are required for your registration and, if so, we help you to prepare and submit 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.
  • Guidance through FDA's UDI and GUDID requirements, help determine the UDI requirements applicable to your specific devices, and facilitate communication with FDA.




1 Establishments engaged in certain activities must pay a required U.S. FDA User Fee. The U.S. FDA establishment registration User Fee for FY 2017 is $3,382.



 








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Registrar Corp
144 Research Drive
Hampton, VA 23666 USA
Phone: +1-757-224-0177
Fax: +1-757-224-0179
info@regsitrarcorp.com
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.