Medical Device Registration in Russia and the EAEU
We support medical device registration from strategy to market access
Gentimed Consult helps Russian and foreign manufacturers register medical devices in Russia and the EAEU. We take over the regulatory part of the project: product analysis, registration strategy, documentation preparation, dossier compilation, testing organization, submission and support for responses to comments.
The team has worked with medical devices since 2019 and understands the procedure not only as a consultant, but also as a market participant. This experience helps us account for regulatory requirements and the client’s commercial interests at every stage.
EAEU National and Eurasian requirements
Services
In 2026, medical device registration remains a mandatory process for entering the Russian and EAEU markets. It is important to determine the risk class, document package, testing and submission procedure in advance to avoid losing time on revisions after comments.
- New rulesResolution No. 1684 strengthened electronic document flow and shifted the focus from a paper certificate to a registry entry.
- DocumentsWe review technical, operating and registration documentation before submission to reduce the risk of refusals and delays.
- StrategyWe select the action plan based on the device, risk class, target market and readiness of source materials.
- SupportWe manage the project from initial analysis to submission, communication with process participants and responses to comments.
Main support areas
We help cover key registration tasks: from strategy and documentation to testing, inspection and support after the device enters the market.
Cases
Experience registering medical devices across a wide range of fields and complexity levels, from gloves to high-tech equipment.
Apro Korea, South Korea
High-tech equipment used for radiofrequency denervation and the treatment of chronic pain syndrome.
Doratek, Turkey
Implantable systems for spinal fixation and stabilization, used in the treatment of spinal injuries, deformities and degenerative diseases.
HpBio, Brazil
Shunt systems designed to drain excess cerebrospinal fluid in hydrocephalus.
Science Medical, South Korea
A high-speed drill used in neurosurgical, spinal, trauma and orthopedic procedures where high precision and instrument reliability are required.We manage the project
using a clear strategy
We present the project as a clear sequence: first we analyze the device and documents, then prepare the dossier, testing, submission and responses to comments.
Cost depends on risk class, document package and registration strategy
The preliminary cost of support is determined after analysis of the device and source documentation. Price depends on risk class, device type, missing documents, need for technical, toxicological or clinical testing, comments and selected registration strategy.
Testing, state fees, translations and notarization are paid separately. After the initial consultation, we prepare a preliminary estimate of timelines, budget and scope.
Indicative support cost:
- Risk class 1 — from 600,000 RUB. Suitable for devices with a simpler strategy; the scope is clarified after checking the device purpose and documents.
- Class 2a — from 1,200,000 RUB. Usually requires more detailed documentation, testing planning and control of dossier preparation timelines.
- Class 2b — from 2,000,000 RUB. Requires extended risk analysis, testing, evidence base and support for responses to comments.
- Class 3 — individually. Cost is calculated after detailed analysis of the device, strategy, testing scope and registration materials.
This approach helps estimate medical device registration timelines, dossier preparation scope, testing budget and possible additional expenses in advance. After the initial analysis, we prepare a preliminary estimate and work plan for registration in Russia and the EAEU.
Projects, countries and confidential experience
The Gentimed Consult team has supported registration projects for manufacturers and suppliers from Russia, South Korea, China, Turkey, Brazil, Spain, Germany and other countries.
We work with medical device registration, dossier amendments, documentation preparation, testing organization, post-registration support and tasks for foreign manufacturers: document adaptation, authorized representative functions and preparation for production inspection.
Some projects cannot be disclosed publicly due to NDAs and commercial sensitivity. Therefore, experience can be presented in anonymized form: by countries, device types, registration strategies and completed tasks without disclosing clients or commercial details.
Frequently asked questions about medical device registration
Yes, legal circulation of a medical device in Russia requires registration under the established procedure. During consultation we help determine whether your product is a medical device and which registration strategy applies.
The procedures differ in requirements, review strategy, document package and possibilities for further device circulation. The choice depends on the manufacturer’s goals, device type and planned markets.
The document package depends on the device, risk class and registration strategy. Technical, operating, registration and supporting documentation is usually required, along with testing materials.
This area may include technical specifications, instructions or user manuals, regulatory documentation and other documents required for the registration project.
Depending on the device, technical, toxicological and clinical testing may be required. The necessary scope is determined after analysis of the device and documentation.
The timeline depends on risk class, document readiness, testing requirements, selected procedure and comments. A preliminary schedule can be determined after initial project analysis.
Cost depends on risk class, device type, documentation scope, missing materials, testing, translations, notarization and support for responses to comments.
Testing, state fees, translations, notarization and other external expenses may be paid separately. We identify these items in the preliminary estimate in advance.
Comments should be analyzed, the scope of corrections determined and a response prepared with updated documents. We support this stage and help close dossier questions.
Yes, we support foreign manufacturers entering the Russian and EAEU markets, including documentation adaptation, dossier preparation, testing, authorized representative functions and production inspection.
