Instructions for completing this form:

This is a proposed contract only (!)

Please fill the company and product information in the proper

places and e-mail this proposed contract to
[email protected] . We will send you a quote based on the
information being provided within the 48 hours.

Until this proposed contract is signed by both parties, there is no

obligation by any of the parties to accept the services or the
prices indicated in this form.
 US Regulatory Agent
A member of the Arazy Group
Medical Device Consultants
www.arazygroup.com

MEDES USA INC.

DESIGNATED AGENT AGREEMENT

The following is an agreement between <company name > < company full address > , (to be
referred to as the “Company”) and Medes USA, Inc., (to be referred to as “Medes USA”) 16505 NE 50th
way P.O. Box 2975 Redmond WA 98052 USA, of <date>, appointing Medes USA to act as the
Designated Agent (DA) for the Company, as per the US Food and Drug Administration (FDA)
requirements 21CFR Parts 207, 607 and 807 for foreign manufacturers who are engaged in the
manufacture, preparation, propagation, compounding, or processing of a drug or a device that is imported
into the United States.

The agreement will commence on the date of receipt of a signed copy of this agreement along with the
payment in full for the services rendered hereunder. This date will be considered as the date of the annual
renewal of the contract.

This agreement is authorizing Medes USA to present itself with the FDA as the Company's DA, to speak
with FDA on behalf of the company, and to discuss proprietary information about the company or the
product.

Service Profile
Medes USA will assume responsibilities as the Company's Designated Agent to perform the following
tasks:

Keep an office in the USA

Assisting FDA in communicating with the foreign establishment;
Responding to FDA questions regarding the establishment's products;
Assisting FDA in scheduling inspections of the foreign establishment;
Updating the Company’s establishment registration and product listings forms.
IF FDA is unable to directly or expeditiously contact the foreign establishment, receiving
information from FDA. Such receipt of information will be deemed to be equivalent to providing
the information directly to the foreign establishment.

It will be the responsibility of the Company to provide the following information to Medes USA so that
Medes USA can perform the above referenced tasks in accordance with the regulatory requirements:
Provide Medes USA an update of changes to the Establishment registration (i.e. address, change
in ownership, Contact details, change is major operation, etc.).

16505 NE 50th way P.O. Box 2975 Redmond WA 98052 USA.

Tel: +425 894-9621 Fax: +425 869-9397 E–mail: [email protected]

All rights reserved Copyright © 2006 Medes USA Inc ("Medes"). This document or any part thereof may not be
used, copied, exhibited or publicized, other than by the express written permission of Medes. Other usage may be
subject to prosecution.
 US Regulatory Agent
A member of the Arazy Group
Medical Device Consultants
www.arazygroup.com

MEDES USA INC.

Notify Medes USA of any new products which is being introduced into the USA market or any
changes to already listed products with the FDA (Removing products, new brand names etc.).

Our initial fees are (please check your choice of our services):

a. -$ - For appointing Medes USA to act as <company name >designated agent only
for products listed in the following table.
b. -$ - Item a. + Initial Registration of <company name > and Listing of your products
with the FDA, as listed in the following table.

Number of
Product Category Class products under
category
<product category 1> I
<product category 2> I
<product category 3> I
<product category 4> I
<product category 5> I

c. Annual renewal of services, starting from the second year (please check one of the following
options):
For one (1) year -$
For three (3) years (25% discount) -$

Payments & terms:

Initial Fees: 80% upon contracting, 20% upon completion of registration.
Annual renewal: Prepayment - 4 weeks before the intiation of one (1) year service.
The fee includes 15 hours of service per year. Any additional time will be charged at $90 per
hour.
Adding new products to an existing service contract - $250.00

16505 NE 50th way P.O. Box 2975 Redmond WA 98052 USA.

Tel: +425 894-9621 Fax: +425 869-9397 E–mail: [email protected]

All rights reserved Copyright © 2006 Medes USA Inc ("Medes"). This document or any part thereof may not be
used, copied, exhibited or publicized, other than by the express written permission of Medes. Other usage may be
subject to prosecution.
 US Regulatory Agent
A member of the Arazy Group
Medical Device Consultants
www.arazygroup.com

MEDES USA INC.

Contract is renewed automatically every year for a full year service, unless written notice has been
given from customer 30 days before renewal date.
Termination is possible at all time by both parties, on a 30 days written notice received by
registered mail or a "confirmed receipt" e-mail by the receiving party. There is no refund if
Contract is terminated by the Client before the completion of full one year service.
All information will be kept in full confidentiality. Sharing propriety information with the FDA
will always be subjected to pre approval of the Company of the content and scope of information.
This contract is subjected and governed by USA law only. Any legal dispute concerning this
contact and or services will be resolved in the state of Washington, USA.

I fully understand the requirements of this agreement and my obligations and want to retain Medical
Device Services USA, Inc. as our US FDA Designated Agent to comply with the FDA regulatory
requirements that commence on February 11, 2002.

for for

signature signature

print name and title print name and title

<company name > Medes USA, Inc.

< company full address > 16505 NE 50th way
Redmond WA 98052
<COUNTRY> USA
tel: <tel>
fax: <fax>
e-mail: <e-mail>
website: <url>

date date

16505 NE 50th way P.O. Box 2975 Redmond WA 98052 USA.

Tel: +425 894-9621 Fax: +425 869-9397 E–mail: [email protected]

All rights reserved Copyright © 2006 Medes USA Inc ("Medes"). This document or any part thereof may not be
used, copied, exhibited or publicized, other than by the express written permission of Medes. Other usage may be
subject to prosecution.