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In June 2018, the Russian Government recommended significant multiple changes in the method of registration of medical devices in Russia.
Recently, the changes of the resolution #633 by the Russian Government coordinated Russian medical device registration requirements with Eurasian regulations. It also focused to clarify the In vitro diagnostic (IVD) and MD approval methodology.
The IVD products refer to those reagents, instruments, and systems proposed explicitly for use in the diagnosis of disease or other conditions, comprising a determination of the state of health, for prevention and treatment of a disease or its sequelae. These products are utilized in the collection, preparation, and examination of specimens drawn from the human body.
Earlier in the month of June 2018, the Russian Government released the resolution #633 and recommended significant multiple changes in the method of registration of medical devices in Russia. It provided:
Medical Devices In Russia
Russia Released Multiple Changes in Medical Device and IVD Registration Requirements
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