Russia Regulatory Framework Medical Device registration

Russian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Russian market:

Major Regulations

On Health protection in the Russian Federation 2012
Approval of RZN Administrative Regulations of Medical Device Registration 2013
Changes to the list of all products subject to conformity procedure in Russia 2010
Federal law on Technical regulations 2012
Regulatory Framework for Medical Devices 2012
Rules for Technical, Toxicological, and Clinical Tests 2014

General Guidance Documents

Testing Regulations 2011

Specific Guidance Documents

Approval of Nomenclature classification for Medical devices and IVDs 2012
Medical Device Safety, Quality and Effectiveness Monitoring – Order 174n 2015
On Approval of Medical Device Safety Monitoring Procedure – Order 175n 2012
Reporting of Adverse Events – Order 12n 2012
Risk class classification of medical devices only2000
Rules for testing medical devices with a measuring function 2012


Reach out to us and we will help you clarify your situation