Regulatory Authority

Roszdravnadzor (Federal Service on Survelliance in Healthcare of Russian Federation)


I, IIa, IIb, III

Quality system

ISO 13485:2016 and ISO 9001

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.

Useful information

Usually, samples are required for on-site testing.

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