US Agent Services (FDA Official Correspondent)

One of the Food Drug Administration’s (FDA) requirements is that all Medical Device and In Vitro Diagnostics companies without a presence in the United States (US) must appoint a registered US Agent. This person must be a resident of the United States or maintain a physical place of business in the US, also the US Agent must be available to answer the phone or have an employee available to answer the phone during normal business hours, which makes RQMIS a perfect fit and a perfect solution for you.

As an FDA US Agent (FDA Official Correspondent), RQMIS can assist with your FDA registration. Establishment registration utilizing the FDA Unified Registration and Listing System (FURLS) is the first step in reaching US markets with your medical device.

Registration requirement applies to the following categories of foreign establishments:

  • Primary Manufacturers
  • Contract Manufacturers and Remanufacturers
  • Contract Sterilizers
  • Foreign Exporter of devices located in a foreign country
  • Specification Developers/Reprocessors of single use devices

As your US Agent, RQMIS will:

  • Assist FDA in communications with your non-US establishment
  • Respond to questions concerning your non-US establishment’s devices that are imported or offered for import into the US
  • Assist FDA in scheduling inspections of your non-US establishment
  • Assist with FDA inspections
  • Receive information or documents from the FDA on behalf of your non-US establishment in the absence of effective communication between the two entities

As your Official Correspondent, RQMIS will:

  • Handle annual registration and listing
  • Creating new registrations and listings
  • Canceling obsolete registrations and listings
  • Changing/updating registration and listing information
  • Maintain and a current list of officers and directors and submit it to the FDA upon request
  • Receive pertinent correspondence from the FDA on your behalf.
  • Report adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations)

Need a US Agent?

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