Medical products may continue to be authorized under national rules. The Eurasian Economic Union (EAEU) has extended the transition period for the introduction of a unified system for the registration of medical devices. The relevant amending protocol to the sectoral agreement was signed by the Member States on 29 December 2025.
A new order has approved the list of medical devices classified as measuring instruments and defined a new procedure for their testing. For the state registration and market release of these medical devices, type approval testing as measuring instruments is mandatory.
On March 1, 2025, new rules for the state registration of medical devices came into effect in Russia. The new rules are introduced by the Russian government decree No. 1684 dated November 30, 2024. These changes aim to simplify and digitalize the procedures but introduce additional requirements for manufacturers and suppliers. These changes apply only to the registration of medical devices according to Russian national regulations.
The Federal Agency for Technical Regulation and Metrology (Rosstandart) passed five new national GOST standards for devices for in-vitro medical diagnostics
