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New EEU medical regulation planned for Russia

August 6, 2015

UL staff member, Svetlana Lagaude presented “Clarifying the key elements of the Russian Federal Law on Medical Devi at Informa’s “Medical Device Regulatory Affairs in Emerging Markets” June 20-22 in Berlin.  At that event, she learned of a new EEU medical regulation planned to come into force in Russia, Kasakhstan and Belorussia (soon Armenia), estimated to be in effect 1 Jan 2016 in accordance with and international agreement within EEU, that will define the common principles and rules of circulation of medical devices. This date is not confirmed and will depend of different factors.

 

According to this new regulation -

Medical devices that have passed the registration procedures established within the framework of the EEU ….shall be marked with a special mark …prior to their market entry…

 EAC Mark

 A transition period will be required between the date of coming in force of this regulation and 31 Dec 2021.

 

When it comes into effect, medical companies will need to apply for new registration.

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