Category Archives: Analytics

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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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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Analysis of recommendation No. 17 of Federal Service for Surveillance in Healthcare

The transfer of Russian economics to Eurasian Economic Union leads on the changes in the routines of State registration for medical devices. One of the recommendation of Federal Service for Surveillance in Healthcare, concerned with the Russian transfer to Eurasian Economic Union is (Recommendation No. 17). It contains the list of standards, the application of which, on a voluntary basis,

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Aspects of Registration of Medical Devices Containing Pharmaceutical Drugs

Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity, technical and functional characteristics, a special category of devices should be singled out: devices containing pharmaceutical drugs. Any manufacturer intending to obtain state registration for such devices in the Russian Federation will find it useful to learn in advance about certain possible difficulties

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