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  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
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News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

RAPS
September 09-12, 2017
National Harbor, MD, USA
Booth #537



Join us!

RAPS Twin Cities Chapter
September 07, 2017
Minneapolis-Saint Paul, USA
(more details coming soon)

RMD 2017 Europe
06-07 October, 2017
Berlin, Germany


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Medical Devices registration in the USA: FDA-Registration and Listing


Manufacturers and distributors placing on the market or distributing medical devices in the United States of America for commercial purposes are required to register them with the FDA

The companies  required to register, have to list their devices, their functions and activities performed using these devices and update them once a year. Registration and listing information is submitted using FDA's Unified Registration and Listing System (FURLS) or the Device Registration and Listing Module (DRLM). 

For product registration with the FDA, the companies have to pay an annual user fee. MDSS Consulting GmbH performs the establishment registration and device listing on the behalf of our clients.

We would also be happy to support you if you want to place your products on the US-American market for the first time. We will advise you on which is the correct registration procedure for your product.


OUR CONSULTING SERVICES IN OVERVIEW