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: https://www.thema-med.com/russia-ad-oggi-effettiva-la-nomina-di-un-rappresentante-autorizzato-in-loco/?lang=en).
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:http://government.ru/docs/7104/.