Starting from January 2013, the Russian Regulatory Authorities have been carried on some changes in the registration procedures that are progressively coming into effect.

As stated in point 2 of the Resolution 1416 – approved on December 27, 2012- the replacement of Medical Devices/IVD and kit certificates is required if:

  • certificates have not expiry date;
  • certificates were issued by the Russian Authorities before January 1,2013.

To proceed with the replacement of the registration certificates appointing of a local Authorized Representative is required (for more information see:

Starting from January 1, 2017, only devices covered by the new certificates will be able to be marketed in Russia.

This replacement will take some time: so it is important to start the procedure at the soonest.

For further information:

Go to Country