Process of registration of medical devices in Russia

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Medical Device and IVD Registration in Russia

In the Russian Federation, in the same way as almost all the countries of the world, all medical devices, both invasive and non-invasive, must be registered with the central department of the Federal Service for the surveillance of public health and for diagnostic and therapeutic purposes. of social development (Roszdravnadzor), who at the end of the registration process issues the certificate (Регистрационное удостоверение на медицинскую технику) known as RY.

Depending on the type of product that is going to certify this certification in addition to the normal indications (Manufacturer's name, name of the device, field of use, etc.) will contain in the case of "complex" devices an attachment in which all are specified the modules that compose it and any accessories with which it is or can be supplied. 

As can be clearly seen, the registration of a medical-health product is a long and complex certification and the documents required obviously vary depending on the type of product that is going to be certified and any requests from the Russian Ministry of Health;

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