All Non-USA manufacturers of medical devices who wish to market their products under their own name in the US market must appoint a Regulatory Designated Agent in order to meet the FDA requirements.

One of the most important choices you, as a manufacturer of medical devices and / or laboratory equipment, will make is to appoint a proper authorized Regulatory Designated Agent.

Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent. We have been serving hundreds of companies worldwide since the new FDA regulation came into force on April 2002.

From the very moment you appoint us as your Regulatory Designated Agent for the FDA, we will take care of all your regulatory affairs tasks: registration and listing of devices and manufacturers, correspondences with the FDA, complaint handling and reporting regulatory issues to FDA.

For more information about our Regulatory Designated Agent services, or instant 24 hours standard contract application or special “Universal Authorized Representative™” package, please submit your inquiry or choose to consult our online experts right now.