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Multiple GOST R Medical Device Representatives in Russia

Y

youuu

#1
Hello everyone!

First I apologize for my lack of knowledge in approvals or certification processes since I am new to this job. So please don't get mad at me for not making any sense :bonk:.

Our company is trying to get GOST-R certification in Russia.

We currently have a representative in Russia(did not get the certification yet) however, I have been informed that unlike Brazil, multilple representatives are accepted to get certified/approval within Russia (just like in US).

Our Russian representative have disappointed us so far so we are considering of assigning other representative to get approved in parallel with the existing representative.

I have checked with one consulting company that this is in fact true but I need more support that it is actually true to go on with this plan!
please confirm me this is true!

thank you sooo much

plus, any information regarding GOST-R will be appreciated !
:thanx:
 
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Y

youuu

#3
Thank you very much Stijloor :D !
Just for the information, I have figured out that having multiple representatives in Russia is currently acceptable (it wasn't in 2012).
 
T

tmcompl

#4
Hello Youuu:
Thanks for the information that multi-representatives in Russia is allowed. So which clause says it if you don't mind to share?

Hello Everyone:
Sorry being a newbie. In Russian Registration, if in our IEC report, we declare the product name "X" and product model number "XX", due to the market taboo of the product name "X", can we change to "Y" while keeping the product model number “XX” the same?

much thanks for your kind support
 
A

Alstanaka

#5
Hi Everyone...
We got a distributor in Russia since 2011, he started the registration of our products there but he never sent us a report of the registration, if he really started or not. In the mean time he asked us a "Power of Attorney". Someone here knows if we can check through internet if he started the process or not and if other distributor can start the registration due the power of attorney with old distributor or if we need do something for to cancel it. Waiting dears.. Thanks!!
 
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