Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

US Agent and EU Authorized Representative (AR)

One of the FDA's many requirements is that all medical device and IVD companies without a presence in the 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, which makes RQMIS a perfect fit.

The EU has a similar requirement where a representative must be designated by non European Union (EU) manufacturers to represent them in the EU and ensure their compliance with the European Directives - this representative is called an Authorized Representative or AR for short.

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 Authorized Representative, RQMIS will:

  • Assist with device registrations and listings
  • Be identified on device product labeling throughout Europe
  • Make available to Competent Authorities (Ministries of Health, etc) a current copy of the device Technical File(s) and/or CE Declaration of Conformity for inspection
  • Assist the manufacturer and its distributors with Incident and Field Safety Corrective Action (FSCA) reporting
  • Assist with Competent Authority or Notified Body inspections

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