The Ministry of Health of the Russian Federation has prepared a draft order to repeal the existing administrative regulation of Roszdravnadzor governing medical device registration under the Eurasian Economic Union (EAEU) framework. The draft is now open for public consultation, which will close on September 9, 2026.
https://pharmvestnik.ru/content/news/minzdrav-rf-otmenit-administrativnyi-reglament-po-registracii-medizdelii-v-ramkah-eaes.html
The administrative regulation subject to repeal was enacted via Order No. 133n dated March 27, 2017. Formulated in accordance with Resolution No. 46 issued by the Eurasian Economic Commission on February 12, 2016, it governs state‑run medical‑device registration services delivered by Roszdravnadzor. It sets forth full‑cycle requirements for registration, safety assessment, quality review and performance evaluation of medical devices, and has long served as the core operational document for implementing EAEU medical‑device registration in Russia.
Per the draft order, the 2017 regulation will not be revoked immediately. It shall cease to be legally effective only after Roszdravnadzor finalises, officially issues and registers a new equivalent administrative regulation.
This regulatory update aims to align administrative procedures with Russia’s currently‑enforced legislation, notably the new Rules for State Registration of Medical Devices established under Russian Government Resolution No. 1684 dated November 30, 2024. The 2017‑era regulation is no longer consistent with superior legal provisions, necessitating a full replacement.
It is worth noting that the Russian government previously revised time limits for updating information pertaining to authorised representatives for medical devices. The upcoming repeal and replacement represent another milestone in the continuous evolution of Russia’s medical‑device regulatory system.
