Registration of medical devices according to the EAEU rules is carried out in accordance with EEC Council Decision No. 46. The procedure allows obtaining a registration certificate valid in the territory of two or more countries of the Eurasian Economic Union.
Registration procedure stages:
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Preparation of technical and operational documentation — including the product dossier, instructions, reports, and translations in accordance with the unified EAEU requirements.
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Conducting the necessary tests — technical, toxicological, clinical, as well as tests for electromagnetic compatibility and metrological tests.
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For high-risk class devices — inspection of production sites
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Dossier submission — registration of a medical device according to EAEU rules includes submission of documents and interaction with comments from the registration authorities of the participating countries.
The process is applicable to all types of medical devices.
Despite the positive intent, the procedure has not yet taken root well in the market: from 2016 to 2025, all five Union countries have issued fewer than one hundred registration certificates under the EAEU rules.
We do not recommend choosing this path from the point of view of economic feasibility. Our expert position is that it is faster and cheaper to carry out national registration of a medical device in the countries of the Union of interest.
If you need consultation on EAEU medical device registration or are considering EAEU medical device registration as an alternative to the national procedure — our experts will help assess the timelines, risks, and the optimal market entry path.