Non-U.S. Medical Device Establishments 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.  As Official Correspondent, RSQM Associates will receive all correspondence from the U.S. FDA on your behalf, and help you in creating any necessary responses.  Our services include:

  • Helping determine whether registration exemptions apply and, if not, we will draw up and submit your registrations with U.S. FDA.  Any needed changes, updates and cancellations will be done at no extra cost.
  • Working with you to determine if U.S. FDA Medical Device User Fees are required for your registration.  If so, we will help you prepare and submit your payment per established requirements.

  • Work with your customers who would like assurance you have a current and valid U.S. FDA Registration. We will issue a Certificate of Registration for you in these situations.

  • We will also submit and maintain your device listings with FDA.


Our fee for this service is $645 US per year.
1 Medical Device Establishments are required to pay an annual registration fee.  In 2014 the fee is $3,313.