Category Archives: MD regulation

Changing in Regulation for medical devices – the biggest from 2013

Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration uses fast track for 1 risk class devices Government could changes classification rules (4n code) – and in this case code will be changed automatically by informing holder Permission of samples import – as a

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Medical device labeling

Today we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last

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The number of stomatology material samples for biocompatibility studies

In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number

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Technical regulation in Russia. Introduction

Dear colleagues, we will start our journey into the secrets of Russian standards, concerned with medical devices with a short review of the technical regulation in Russia and the exploration of certification systems GOST, GOST R, GOST R IEC and GOST R ISO. The certification system GOST R – is the biggest certification system in Russia. Moreover, this is the

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Biocompatibility trials for software as medical device

Software as a Medical Device (SaMD), in other terms – «software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device» (according to the definition of U.S. Food & Drug Administration), is rather new term in the field of Medical Device state registration in Russia. There are a

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