Russian Medical Device Regulations for Multiple Brands of the same Product
- Thread starter pkost
- Start date
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!
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!
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.
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!