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Russia Medical Device Regulations

Major Regulations

On Health protection in the Russian Federation (Russian) Federal Law N 323-FZ06/2012
Approval of RZN Administrative Regulations of Medical Device Registrationen Order No. 737n10/2013
Changes to the list of all products subject to conformity procedure in Russia (Russian) Decree No. 90611/2010
Federal law on Technical regulations (Russian) No. 184-ФЗ07/2012
Regulatory Framework for Medical Devices, as amended on July 17, 2014en Decree No. 141612/2012
Rules for Technical, Toxicological, and Clinical Tests (Russian) No. 21410/2014

General Guidance Documents

Testing Regulations (Russian) RS-00212/2011

Specific Guidance Documents

Approval of Nomenclature classification for Medical devices and IVDs (Russian) MOH Order N 4н06/2012
Medical Device Safety, Quality and Effectiveness Monitoring - Order 174nen Order 174n12/2015
On Approval of Medical Device Safety Monitoring Procedure - Order 175nen Order 175n09/2012
Reporting of Adverse Events - Order 12nen Order 12n06/2012
Risk class classification of medical devices only (Russian) en GOST R 51609-200005/2000
Rules for testing medical devices with a measuring function (Russian) MOH No. 8908/2012

All documents listed below were published by the Russian agency Roszdravnadzor and are in PDF format. The original document was in Russian, and was translated into English using a free translation tool. We have not verified the accuracy of the translation so use it for general informational purposes only.