Medical devices exported to Russia must undergo EAEU registration accepted by Roszdravnadzor, including risk classification, technical documentation, QMS evidence, clinical and performance data, Russian labeling, and an EAEU authorized representative.
Direct answer: Medical devices exported to Russia are registered under the unified rules of the Eurasian Economic Union (EAEU) and accepted by the Federal Service for Surveillance in Healthcare (Roszdravnadzor). The process begins with determining the risk class (Classes 1–3 and implantables, etc.), followed by submission of the technical file, quality management system evidence, clinical and performance evidence, Russian-language labels and instructions for use, and appointment of an authorized representative within the EAEU. Import and sale are permitted only after the registration certificate is obtained. Specific classification determinations and review timelines are subject to the latest requirements of the competent authority; no unified review timeline is officially published.
Key Requirements
- Competent authority: Federal Service for Surveillance in Healthcare (Roszdravnadzor), Russian Federation — https://roszdravnadzor.gov.ru/
- Regulatory framework: EAEU requirements for medical device registration and safety (EAEU Council Decision No. 46 of 2017) — https://eec.eaeunion.org/
- Applicable products: Medical devices classified by risk under EAEU rules (Class 1 is the lowest; Class 3 and implantables are the highest).
- Core documentation: (1) application form and authorized representative documents; (2) technical file and intended-use statement; (3) quality management system evidence (ISO 13485); (4) clinical and performance evaluation data; (5) risk management file; (6) Russian-language labels and instructions for use; (7) manufacturing site information.
- Local representative: Required. Foreign manufacturers must appoint an authorized representative within the EAEU.
- Language requirements: Registration documents and labels must be in Russian.
Professional Notes
Eurasian Economic Commission (EEC) — https://eec.eaeunion.org/
Roszdravnadzor — https://roszdravnadzor.gov.ru/
Prepared by the Ameli Regulatory Editorial Team based on public pages of the target country's regulatory authority. Verification date: 2026-11-02.
Frequently Asked Questions
Do I need to re-register if I already have CE or FDA approval?
Yes. EAEU registration is a separate procedure. CE/FDA documentation may be used as reference technical evidence, but it cannot replace the EAEU registration certificate.
Does the registration certificate have an expiration date?
Under EAEU rules, the registration certificate has no fixed validity period. However, changes must be processed in accordance with the regulations, and post-market vigilance obligations must be fulfilled. Specific requirements are subject to the competent authority.
Can I submit Chinese documents directly?
No. Submitted documents and labels must be in Russian. Some documents require notarization or legalization.
Source and Disclaimer
Sources are the official websites and regulatory pages of the authorities listed above. Verification date: 2026-11-02. This article is a regulatory information summary and does not constitute legal advice. Specific requirements are subject to the latest requirements of the competent authority. Ameli is a regulatory information resource for medical device companies and is not a CRO or an agent.
Need a registration pathway assessment?
Send product type, intended use, target countries and existing certificates. AIMEILI can help evaluate registration pathway, documentation gaps and compliance risks.
Contact AIMEILI