Fees: Medical Device Registration for U.S. Establishments
U.S. Medical Device Establishments that are not exempt from U.S. FDA's registration and listing requirements must designate an Official Correspondent for U.S. FDA communications. As your Official Correspondent, Registrar Corp's team of Medical Device Regulatory Specialists provide guidance on required elements, formats and particularities of submissions for US$ 695 annually including:
- 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 1are required for your registration and, if so, help 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.
Establishments engaged in certain activities must pay a required U.S. FDA User Fee. The U.S. FDA establishment registration User Fee for 2011 is US$ 2,179.
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| 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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