Re-registration of medical device in Russia - "changing holder"

[Rocke]

We need to re-register en IVD in Russia.
The regiatration holder is a Russian Distributor.
Does anybody know if we can change "holders" in the same go as re-registering or will it be all over again if we want to have a different holder?

We have an option in the contract with the distributor, that they need to issue sub-licenses in case we require a different partner to work with our product in Russia, so that is anotuer option.

Any experience appreviated.

Best regards
Camilla

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!