EAEU extends transition period for unified registration of medical devices

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.

The Ministry of Health has updated the requirements for medical measuring devices

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.

Translation and authentication of documents for EAC certification

For some registrations for the Eurasian market, translated and certified documents are requested from the foreign manufacturers. Thus, incorrectly certified documents can lead to delays or even refusal of registration.

The European Commission has published harmonized standards for medical devices

The European Commission has recognized 9 harmonized standards from the International Organization for Standardization (ISO) and the International Electrical Commission (IEC) related to medical devices. These ISO and IEC documents are used unchanged like European standards EN ISO or EN IEC.

Russia introduces new GOST standards for in-vitro medical diagnostics

The Federal Agency for Technical Regulation and Metrology (Rosstandart) passed five new national GOST standards for devices for in-vitro medical diagnostics

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