How Classification Works
Russia's risk-based four-class medical device classification system — how it works and who determines the class.
Class I · IIa · IIb · III Overview
Detailed overview of Russia's four medical device risk classes — characteristics, typical devices, and key regulatory implications.
IVD Classification
How in vitro diagnostic (IVD) medical devices are classified in Russia — four classes based on intended use and patient risk.
SaMD & Software Classification
How standalone software and Software as a Medical Device (SaMD) is classified in Russia under Roszdravnadzor guidance.