Classification of In-Vitro Diagnostic (IVD) products in Russia

Classification of In-Vitro Diagnostic (IVD) products in Russia is based on similar (but not the same!) principles as described in GHTF/SG1/N045:2008 guidance. Classification rules are described in the Decree of the Ministry of Health #4N (Link in Russian) and more detailed specific national standard GOST R 51088-2013 (link in Russian).  Please note that in addition to classification based on safety class there is nomenclature classifier (link in Russian) which should be considered when IVD is submitted for registration. Please find my summary in the slide below:

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