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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Regulatory Agent Services

In order to assist you, or to provide you a quote for our Regulatory Agent services, please fill-in the following form:

The fields marked whit asterisk (*) are mandatory

Contact Information

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Company Information

Company Name: *

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Product Information

Please fill the following table to the best of your knowledge, leave empty what you are not sure of. Feel free to add more information on the “free text zone” at the end of the form.

FDA Product	Class	FDA Cleared	If “YES” indicate one of the following as adequate:

What do you need? (*)

RA services for already FDA cleared products

RA services and assistance in FDA listing of Class I products

FDA listing of new Class I products

Others

Additional Information

Free text zone

If you use Internet Explorer the free text zone might be restricted to 160 characters. Other navigators do not have this limitation. If you need to send us a longer text, please e-mail it to medes@arazygroup.com. Do not forget to mention your contact information in such e-mail. Thank you!