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.
Under the revised timeline, applications for registration under national legislation may continue to be submitted until 31 December 2027. At the same time, manufacturers may still opt to use the registration procedures provided for under EAEU law.
The decision is intended to support a gradual integration of national regulatory systems and to reduce the administrative burden on both manufacturers and regulatory authorities. The protocol will be applied provisionally ten days after signature and will enter into force once all domestic ratification procedures have been completed.
How Can We Help?
In this rapidly evolving regulatory environment, Schmidt & Schmidt offers comprehensive support for exporters to EAEU countries. Our range of services includes EAC certification, adaptation to specific product categories, and customized solutions to meet the technical and legal requirements of these markets. We are committed to making market entry and expansion in these regions easier for companies by providing up-to-date information and guidelines.
Technical expertise, attention to detail, and accuracy in document preparation are essential for the smooth distribution and use of products, machinery, or equipment within the EAEU. Technical documentation must also be written in Russian or the official language of the member country in which the product is sold or used. To avoid any issues, we are happy to assist you in preparing new technical documentation or reviewing existing documents for completeness and linguistic and terminological accuracy in Russian.
Thanks to their many years of experience, our experts can also offer you specific industry knowledge in the fields of plant engineering, mechanical engineering, metalworking, metrology, electrical engineering, automation, medical technology, food processing, and the furniture industry.
What is an EAC Certification?
In our video, we explain what an EAC Certification is and how and where to certify or declare your products for the introduction on the EAEU market.
The EAC Certification and the EAC Declaration are complex procedures that attest your products the conformity with the technical regulations of the EAEU and require a lot of know-how. Schmidt & Schmidt will support you with the certification of your products for the EAEU market.
