Russia runs two device registrations, not one

Two systems, one choice

A device sold in Russia can currently clear either of two registration systems. The national route runs through Roszdravnadzor, Russia's health-products regulator, and the registration it issues is valid in Russia alone. The other route runs through the Eurasian Economic Union's own unified procedure, and a registration granted under it is valid across all five EAEU member states at once — Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan — without a separate national filing in each. For a new device entering the Russian market today, choosing between the two isn't yet forced; both routes are open, and a manufacturer picks based on which countries it actually needs covered and which dossier it would rather build.

The deadline to retire the national track keeps moving

The EAEU-wide system was meant to fully replace national registration on its own schedule, and that schedule has already slipped more than once. The most recent extension traces to a protocol the Eurasian Economic Commission's member states signed on December 21, 2025, carried into Russian law through Government Resolution No. 2214. Under that extension, new national registrations are still accepted through December 31, 2027; amendments to registrations already on the books can run through December 31, 2028; and the EAEU route becomes the only option for new registrations starting January 1, 2028. Earlier versions of this same transition named earlier cutoff dates that came and went without the national route actually closing. The durable fact isn't any one of these dates — it's that the cutoff has moved before and the current one is not guaranteed to be the last.

The two systems don't expire the same way

A national registration's own validity and renewal terms run under Roszdravnadzor's longstanding domestic framework, untouched by whatever is happening at the union level, and cover only the one country regardless of how that framework treats renewal. An EAEU registration, once granted, functions across all five member states under the union's own rules — and it's the only one of the two that's built to survive whenever the eventual cutover actually happens, since the national route is the one scheduled to close, not the EAEU one.

Going wide isn't the easier filing

Covering five countries instead of one isn't free. The EAEU's own conformity-assessment requirements for the unified procedure — the technical tests, toxicological studies, and clinical trials a dossier has to carry — are set at the union level and are themselves still being updated; a new EAEU conformity-assessment procedure is set to take effect in September 2026. A manufacturer choosing the EAEU route for broader reach is accepting a dossier built to a harmonized standard it doesn't fully control the timing of, not a shortcut around the national route's own requirements.

Where this meets the file

A Russia row in a cross-border registration tracker needs which system a device is actually registered under — national or EAEU — carried as its own field, alongside that system's own validity and renewal terms, and the current transition deadline flagged as a value to re-verify at each use rather than a date copied once and trusted. A registration tracker built around that structure, alongside the launch catalog's other cross-border templates, is previewed there now. If your program has tracked Russia's two systems differently, the shelf takes that correction directly.