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
Document Number Published Language
Download Rules for Technical, Toxicological, and Clinical Tests (Russian) No. 214
Download Federal law on Technical regulations (Russian) No. 184-ФЗ 07/2012
Download On Health protection in the Russian Federation (Russian) Federal Law N 323-FZ 06/2012
Download Changes to the list of all products subject to conformity procedure in Russia (Russian) Decree No. 906 11/2010
Download Approval of RZN Administrative Regulations of Medical Device Registration Order No. 737n 10/2013 English
Download Regulatory Framework for Medical Devices, as amended on July 17, 2014 Decree No. 1416 12/2012 English
General Guidance Documents
Document Number Published Language
Download Testing Regulations (Russian) RS-002 12/2011
Specific Guidance Documents
Document Number Published Language
Download Rules for testing medical devices with a measuring function (Russian) MOH No. 89 08/2012
Download Risk class classification of medical devices only (Russian) GOST R 51609-2000 05/2000
Download Approval of Nomenclature classification for Medical devices and IVDs (Russian) MOH Order N 4н 06/2012
Download Medical Device Safety, Quality and Effectiveness Monitoring - Order 174n Order 174n 12/2015 English
Download Reporting of Adverse Events - Order 12n Order 12n 06/2012 English
Download On Approval of Medical Device Safety Monitoring Procedure - Order 175n Order 175n 09/2012 English
Download Risk class classification of medical devices only GOST R 51609-2000 05/2000 English