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Fees: Registration and U.S. Agent Requirements for 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. Having Registrar Corp as your U.S. Agent prevents conflicts of interest that may arise when importers or brokers serve as U.S. Agents. As official correspondent, Registrar Corp will receive correspondence from U.S. FDA on your behalf, and assist you in formulating any necessary responses. The fee for Registrar Corp to serve as your U.S. Agent and Official Correspondent is US$ 695 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.




1 Establishments engaged in certain activities must pay a required U.S. FDA User Fee. The U.S. FDA establishment registration User Fee for 2014 is US$ 3,313.



 







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.

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