Roszdravnadzor (Federal Service on Surveillance in Healthcare of Russian Federation)
I, IIa, IIb, III
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.
Usually, samples are required for on-site testing.