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After the changes in Russian medical device registration rules by the Russian government; now, instead of the two-step evaluation procedure, all IVDs will pass by a one-step evaluation method.
Alexey Stepanov recently represented an update on medical device regulations in Russia, Eurasian union and Kazakhstan. The medical devices are an integral part of treatment. The device can be anything; an instrument, machine, implant or software which is intended for diagnosis and monitoring the disease. The changes done in medical device regulatory of Russia, Eurasian union and Kazakhstan are explained below:
Russia
In the starting of June 2018, the Russian government introduced significant changes in the Russian medical device registration rules. Now, instead of the two-step evaluation procedure, all IVDs will pass by a one-step evaluation method.
The next noteworthy change in medical device authorization is the replacement of pharmaceutical component registration with the confirmation of drug component quality as per country regulations.
The categorization as per design or product changes have been considered. A few more variations on the small level were done to make the medical device authorization simpler and similar to Eurasian medical device registration rules.
Eurasian Union
The Eurasian union on 22 June 2018 updated the recommendations to interpret whether a product is categorized as the medical device or not as per Eurasian medical device regulations terms.
The report categorize products as general purpose products, medical devices, assistive/rehabilitation products, in-vitro devices, medical furniture, physiotherapy devices, disinfectants, cosmetic/toiletry products, medical packaging, medical devices with a drug component, products for sports or leisure, medical software and personal protective equipments.
The criteria of identification can also be used in documentation prepared for medical devices registration and in evaluating medical devices efficacy.
Kazakhstan
The ministry of health of Kazakhstan introduced the updated list of medical products on 15 June 2018 to exempt VAT from selling and importing.
Medical Devices In Russia
Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, June 2018
Alexey Stepanov
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