Beawire MD regulation standards

Every GOST R is a National Standard but not every National Standard is GOST R

Technical regulation - 2018. Part 3.

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.