Tag Archives: Head

Telemedicine in Russia – review

Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of

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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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About biomedical cell product

Main information you should know about biomedical cell product in our great update: what is biomedical cell product by law? name of biomedical cell product – how to combine it how to store biomedical cell product (main questions from people who couldn’t understand how this “product” look like)? international regulation safety monitoring – what is the role of manufacturer and

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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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EAC mark – list of applicable standards

A list of standards which, on a voluntary basis, fully or partially ensure compliance of medical devices with the General requirements of safety and efficacy of medical devices, the requirements for their labeling and maintenance documents approved by the recommendation of the Eurasian Economic Commission panel. You could find recommendation #17 by link (in English) – EAC #17 (standards) ; (in Russian)

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Government fees for changing process – updates

Roszdravnadzor starts to charge a fee for all changing process where conclusion from expert center is required. This means that if manufacturer changes product name or provide modernization of product composition, he should pay: Government fee for changing process (Roszdravnadzor staff work) – 1500 Russian Rubles; Government fee for expert conclusion during changing process (depends on product risk class): -1 risk

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