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

Need an AR or US Agent?

You've come to the right place. Give us a call today at (978) 358 7307, or just click here:

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