Medical Devices Sales clearance in the USA: PMN, 510(k), PMA, De Novo, 513g, 515i

Medes Inc – USA: FDA Designated Agent – Arazy Group

If you want to know more about regulatory issues of Medical Devices, click here

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

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What is your ONLY responsibility in relation with your Regulatory Designated Agent before FDA and how we can help you?

Once you appoint us as your Regulatory Designated Agent and you complete FDA requirements, you will be requested, as a foreign establishment to:

Report any case that meets the reporting requirements to the FDA, following the criteria and procedures that we shall provide you. This is the only responsibility you have. We will take things from there with the FDA on your behalf.