On March 1, 2025, new rules for the state registration of medical devices came into effect in Russia. These new rules are introduced by the Russian government decree No. 1684 dated November 30, 2024. These changes aim to simplify and digitize the procedures but introduce additional requirements for manufacturers and suppliers. These changes apply only to the registration of medical devices according to Russian national regulations.
Transition Period
From March 1, 2025 to December 31, 2025 – Transition to the new rules (Decree No. 1684).
From 2026 onwards, registration should be carried out according to the rules of the Eurasian Economic Union.
New Requirements for Technical Documentation
Previously, documentation requirements were stricter, but now the regulator grants more flexibility, especially for innovative products. These changes aim to facilitate market access without compromising safety and quality standards.
p>For medical devices of risk classes 2b and 3, a registration monitoring plan is now required. This document describes how the manufacturer will monitor the safety of the product after its market launch.It is permissible to replace technical and operational documentation with other documents from the manufacturer, such as research results or post-market surveillance reports.
New Requirements for Clinical Trials
From September 1, 2025, only electronic submission of trial results will be possible through the Roszdravnadzor system.
The decree defines new requirements for medical institutions that are allowed to conduct clinical trials. These trials may only be conducted by institutions that:
- Hold a medical activity license.
- Have the scientific operation or conduct of studies included in their statute.
- Possess an intensive care unit (except for in-vitro diagnostics).
- Have secure data storage systems.
Electronic Document Management and Personal User Account
All interactions with Roszdravnadzor must now be carried out digitally:
- Through the personal account on the “Gosuslugi” portal
- Through the electronic user account on the Roszdravnadzor website
Documents must be submitted as electronic documents or scanned copies with a qualified electronic signature (QES).
Deadlines for Remedying Deficiencies
Some deadlines have changed: If a submitted application contains deficiencies or incomplete documentation, the applicant is given a period of 30 working days to correct the errors. If this is not done on time, the application will be rejected.
Registration of Multiple Models is Now Possible
The new regulations allow multiple models or brands of medical devices, even if they differ in nomenclature classification, to be grouped into a single registration entry (Point 26 of Government Decree No. 1684).
However, this is only permissible if:
- The products come from the same manufacturer
- Are manufactured using the same technology
- Belong to the same risk class
- Are identical in function and working principle
- Have the same intended use
Additionally, it is allowed if the products only differ in their configuration, but these differences must:
- Not affect function or working principle,
- Expand the specialized application,
- Form a series or group of versions, or
- Possess a common feature structure.
This flexibility is intended to simplify registration without compromising safety or transparency.
Obligations of Foreign Manufacturers
By September 1, 2025, foreign manufacturers must:
- Appoint an authorized representative of the manufacturer or
- Update the details of their already registered representative in the Roszdravnadzor register.
If this is not done on time, the registration certificates will be annulled.
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.
How can we help?
In this rapidly changing regulatory environment, Schmidt & Schmidt offers comprehensive support for exporters to the EAEU countries. Our service portfolio includes EAC certification, customization to specific product categories and tailored solutions to comply with the technical and legal requirements of these markets. We are committed to making it easier for companies to enter and expand in these regions by providing the most up-to-date information and guidelines.
Technical expertise, care and accuracy in the preparation of documents are the prerequisite for problem-free distribution and use of products, machines or systems in the EAEU territory. The technical documentation must also be written in Russian or in the official language of the respective member country in which the product is to be sold or used. In order to avoid any problems, we will be happy to help you create new technical documents or check existing documents for completeness and linguistic and terminological correctness in Russian.
Thanks to their many years of experience, our experts can also provide you with specific industry knowledge from plant engineering, mechanical engineering, metal construction, measurement technology, electrical engineering, automation technology, medical technology, food technology and the furniture industry.
