Russia Medical Device Regulations

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.

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