Medical Devices are subject to registration procedures.
Manufacturers without local presence in Russia must appoint a Local Authorized Representative responsible for submitting the documents required in the registration process to the Roszdravnadzor.
Local Authorized Representative.
Timeframe and fees
Timeframe: 6-16 months.
Labelling and documentation language
Documentation and labelling must be provided in Russian.
Usually, samples are required for on-site testing.