Last September 2018, the Russian Regulatory Authority Roszdravnadzor published the  “Methodical recommendations on the order of examination of the quality, efficiency and safety of Medical Devices (in terms of software) for state registration within the national system” to provide clarifications on the evaluation process of standalone medical software for registration purposes as medical device in Russia.

The guideline contains the classification criteria of the software as a medical device according to its intended use, the rules for assigning the risk classes, the procedure used to conduct the assessment of the technical documentation and a list of recommended standards for the assessment of software compliance through technical tests by an accredited institution.

The purpose of the document, published only in Russian, is to define a uniform approach among the Roszdravnadzor institutions responsible for carrying out the evaluation of the software as a standalone medical device.


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