Regulatory Authority

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


I, IIa, IIb, III

Quality system

ISO 9001 and ISO 13485


  • 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

Labeling and documentation language

Documentation and labeling must be provided in Russian.

Useful information

Usually, samples are required for on-site testing.