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Russia - 1 Registration with Multiple Trade Names

3

3l5m4r

#1
Hi there,

I'm new to this forum and I'm wondering if you could help me out with a question I have concerning Russian regulatory affairs:

Is it possible to market medical devices with identical item numbers (and identical manufacturer, device classification, GMDN codes -- i.e. essentially the same product) under different brands / trade names?

Hope someone has a clue... :)
 
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Stijloor

Staff member
Super Moderator
#2
Re: Russia - 1 registration, multiple trade names

A Quick Bump!

Can someone help with this question?

Thank you very much!
 
L

LFZR88

#3
Re: Russia - 1 registration, multiple trade names

Hi,
Device registration in Russia is massively challenging... there arent any mutual recognition agreements and the process of registration is conducted in Russian. You need an authorised rep, so first I would go about finding one to get advice from.
I don't see any reason why you couldn't do what you are asking, however you will pay for it as registration relies on in country product testing... so each brand would be tested I assume as a separate registration.
Good luck !!
 
3

3l5m4r

#4
Re: Russia - 1 registration, multiple trade names

wow- sounds like a good piece of work...
thanks :)
 
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