Dear colleagues, in this article we give to you the explanation about reasons of using standards of GOST range during the procedure of obtaining registration certificates for medical devices.

The interested sites may have a question: “Must my device comply with National Russian Standards GOST R XXXXX-XXXX, but also with EAC standards with the GOST XXXXX-XXXX, if I would like to get the State Registration for this only in Russia?”.

The answer is very simple.

Over time every Standard gets older. Of course, National Standards of Russian Federation too. And some of these standards are replaced with actual editions of GOST XXXXX-XXXX standards, which become the status of National Standards of Russian Federation.

Let’s examine some popular examples of that standards:

Replaceable GOST R Standard	Replacing GOST Standard
GOST R ISO 11135-2000	GOST ISO 11135-2012
GOST R ISO 11137-1-2008	GOST ISO 11137-1-2011
GOST R ISO 13485-2004	GOST ISO 13485-2011
GOST R ISO 14971-2009	GOST ISO 14971-2011
GOST R ISO 10993 range	GOST ISO 10993 range
GOST R ISO 7864-2009	GOST ISO 7864-2011
GOST R ISO 7886-1-2009	GOST ISO 7886-1-2011

So we hope, that this information will be useful for your understanding of the procedure of State Registration of medical devices.