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