Regulatory Authority
Roszdravnadzor (Federal Service on Survelliance in Healthcare of Russian Federation)
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016 and ISO 9001
The information on this page is valid and current as of March 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
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.
Labelling and documentation language
Documentation and labelling must be provided in Russian.
Useful information
Usually, samples are required for on-site testing.
