Senior USA: FDA Designated Agent – On Line Registration

Medes Inc – USA: FDA Designated Agent – Arazy Group

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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.

Why choose MEDES USA Inc. as your Regulatory Designated Agent before the FDA?

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

Medes USA Inc., located in Seattle WA, is a qualified and recognized Regulatory Designated Agent before FDA. We have been serving tens of companies worldwide since April 2002, when the new FDA regulation came into force.

From the very moment you appoint us as your Regulatory Designated Agent before FDA we shall handle all your regulatory affairs: registration and listing of devices and manufacturers, as well as corresponding, complaint handling and reporting regulatory issues to FDA in the USA.

Medes offices are part of the Arazy Group an international leading organization in the field of Medical Device Consultation. The group has been providing hundreds of companies worldwide with complete range of services, ranging from product regulatory and manufacturer compliance to clinical studies and marketing research.

What if you wish to discontinue?
This is even simpler! Anytime you wish to discontinue our Regulatory Designated Agent services, simply e-mail or fax us. Assuming there are no outstanding payments, our agreement will be terminated within 30 days. FDA will be notified by us.

What are the Responsibilities of the US Regulatory Designated Agent?

The responsibilities of the Regulatory Designated Agent are:

Assisting FDA in communications with foreign establishments,
Responding to questions concerning the products of foreign establishment that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment

Reference for the need to appoint a Regulatory Agent

FDA new regulations implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA)

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.

Services that we offer for FDA clearance

Preparation of regulatory strategy for FDA clearance of any new product you wish to develop, manufacture and eventually export.
Manufacturer Registration and Product Listing of all your medical products with FDA.
Adverse Incident and Recall Reporting to FDA.
Handling of customer complaints received through FDA.
Consultation services related to FDA clearance: regulatory / QA / product compliance of any medical device or laboratory equipment.