SUBMIT INQUIRY
Russia
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 
 
REGULATORY AUTHORITY: Medical devices are regulated by the Roszdravnadzor, the Russian healthcare and social development agency.

CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk-based model into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process ranges from 8 months for Class I devices to 16 months for Class III devices.

LICENSE VALIDITY: Licenses issued in Russia do not expire.    

AUTHORIZED REPRESENTATIVE: A local authorized representative is required to register medical devices in Russia.

Last updated on January 10, 2018.



Interested in obtaining fast market approval for your medical device or IVD in Russia? REQUEST A FREE QUOTE>

For more information on registration in Russia, check out the following articles on our blog:
Country at a Glance: Russia
latest news
  • Oct 3 2018
    REGULATORY UPDATE - LABORIE

    China: Laborie's Aquarius System was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 28 2018
    REGULATORY UPDATE - VAREX IMAGING CORP.

    Canada: Varex Imaging's Nexus DR was approved for sale with LICENSALE.COM®....

    Read More
  • Sep 12 2018
    REGULATORY UPDATE - TECHNOPATH CLINICAL DIAGNOSTICS

    Canada: Technopath Clinical Diagnostics' Multichem A1C was approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 16 2018
    REGULATORY UPDATE - VIASONIX

    Canada: Viasonix' Dolphin family of products was approved for sale with LICENSALE.COM®....

    Read More
  • Aug 8 2018
    REGULATORY UPDATE - ORASURE TECHNOLOGIES

    Nepal: OraSure Technologies' OraQuick HIV Self-Test was approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP