Regulatory Authority

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


Classification

I, IIa, IIb, III


Quality system

ISO 9001 and ISO 13485


Procedure

  • 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.

Applicant

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.