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

Regulation	Year
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

Document	Year
Testing Regulations	2011

Specific Guidance Documents

Document	Year
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 only	2000
Rules for testing medical devices with a measuring function	2012

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