Russian Medical Device Regulations for Multiple Brands of the same Product

pkost

Trusted Information Resource
#1
Does anyone here have experience with the russian medical device regulations?

Specifically, I am hearing that it is not possible to market multiple brands of the same product or carry out any kind of OBL activity - can anyone confirm this?
 
Elsmar Forum Sponsor
#2
I have marketed multiple brands of the same product. If anything has changed you should be able to find it documented somewhere.

Which OBL activities specifically?
 

pkost

Trusted Information Resource
#3
I'm not sure on the details, it was passed on by a commercial colleague, who was interpreting a conversation with a Russian counterpart. I'm therefore trying to clarify exactly what is meant or whether it's valid

We are mostly based in the EU and OBL our products, i.e. take a product that is already CE marked, remove evidence of the original branding and apply our own (we continue to declare the original manufacturer on pack). I have been told that if the original manufacturers product already exists on the Russian market, we cannot then register our product with our brand.

All options for registration are up for discussion at the moment i.e. assuming the regulatory burden ourselves or leaving it with the original manufacturer etc. The road block for us will be if we cannot launch products that have been previously registered by our supplier.

I suspect I will have to go back to the soruce of the rumour to unravel this!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I suspect I will have to go back to the soruce of the rumour to unravel this!
If this is important, I think a more viable path would be engaging an RA professional who is also a Russian literate, and getting some formal advice. I'm quite sure Emergo (no affiliation) can provide such a service.
 

pkost

Trusted Information Resource
#5
I agree, the original source was a regulatory consultant in Russia, but the information was passed to me via a the commercial team so I think there was some loss in translation from Russian regulatory -> Russian commercial -> English commercial -> English regulatory!
 
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