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Russia Regulatory Framework Medical Device registration

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Russian Medical devices regulation basics.

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

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
Regulatory Framework for Medical Devices	2014

General Guidance

File	Year
Testing Regulations	2011

Specific Guidance

File	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

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
Regulatory Framework for Medical Devices	2014

File	Year
Testing Regulations	2011

File	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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