Beawire MD regulation standards

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 only system for mandatory certification in Russia. This system is intended not only for the foreign manufacturers, who must prove that its production accords to Russian standards, but also for Russian manufacturers, whom production is contains in the list of production with mandatory certification. The system GOST R consolidates more than 1500 certification organs (Notified Bodies) and more than 3550 testing labs. The role of coordination center in the GOST R system is divided among each other Federal Service for accreditation (RusAccreditation – website) and Federal Agency on Technical Regulation (RusStandard – website) i.e. Federal Executive Bodies. This is one of the biggest differences from any other voluntary certification system. Let’s mark, that there is also voluntary certification in system GOST R. The system GOST R contains State Standards of the Russian Federation. For example, GOST R 50444, GOST R IEC 60601-1, GOST R ISO 18153. The acronyms IEC and ISO mean that these standards are harmonized with corresponding international IEC and ISO standards.

The certification system GOST realizes the technical regulation by the Russian Interstate Standards. This system was created in the year 1992 by states-participants of CIS (Commonwealth of Independent States). The participants of commission had decided to continue using of actual soviet standards and save the prefix GOST to the numbers of the new interstate standards. In order to accord to the requirements of EEC (Eurasian Economic Commission – so called EAC mark) products must accord to requirements of applicable interstate standards, that was consolidated in 33 Technical Regulations. For now, there is no Technical Regulation for medical devices. But we continue to look after its appearance.

In conclusion we can summarize, that manufacturers, who want to get the state registration for it’s medical device in the Russian Federation and/or CIS must remember, that it’s device has to accord to applicable GOST R and GOST standards respectively.