The Russian government issued the Decree No. 633 “On Amending the Rules for the State Registration of Medical Products”, implementing long-awaited changes to the registration rules of Russian Medical Devices. Aiming to harmonize registration requirements for Russian Medical Devices with the regulations of the Eurasian Economic Union (EAEU), the changes that came into force on June 13, 2018 have a significant impact on the registration procedure of IVD products.
The registration process was simplified from two stages to a single stage for all IVD classes, eliminating several months of the assessment period to obtain authorization for clinical trials. The aforementioned Decree also eliminates the obligation for Class IVD 2a, 2b and 3 manufacturers to request authorization from the competent Russian authority, Roszdravnadzor, for the registration of their products. In addition, mandatory on-site clinical tests for IVDs can also be performed in parallel with the technical assessment before submission to the competent authority.
Another significant change concerns the registration of Medical Devices with a pharmaceutical component. First considered an obstacle when approving these Medical Devices in Russia, Decree No. 633 replaced the requirement for mandatory registration of the pharmaceutical component as a pharmaceutical substance with a new requirement that provides evidence certifying the quality of the pharmaceutical component in compliance with the regulations of the country of origin.
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