01Route
Countries and procedure
A reference state and recognition states aligned with your supply plans. A sequence for registration and recognition.
Outcome: project roadmap
Under Eurasian Economic Union rules
Medical device registration in the EAEU
We help manufacturers and authorized representatives prepare medical devices for registration under Eurasian Economic Union rules. We examine intended use and design, review source documents and develop a project plan.
A device description and your intended destination countries are enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
A dossier for the reference state and recognition states
Four deliverables on the path to registration in the Union.
02Documentation
Description and instructions
Device description, operating documentation and labeling with the necessary translations.
Outcome: consistent documentation
03Evidence
Testing and inspection
Tests and samples, laboratory coordination and preparation for manufacturing inspection where required.
Outcome: supporting evidence
04Expert review
Submission and recognition
Support during review in the reference state and recognition states, including responses to requests.
Outcome: EAEU registration certificate
Project geography
Planning to supply EAEU member states?
The EAEU comprises five member states. For each project, we select a reference state for expert review and registration, and recognition states where the device will circulate. We work through the countries, translations and documentation requirements before submission.
Click a country to make it the reference state. Use the Supply button to mark the recognition states.
How EAEU registration works
Six stages, from source materials to support through the decision. We define each stage's scope after analyzing the device.
01
Device and countries
We examine intended use, composition, risk class and supply plans, and clarify the applicant and selected countries.
Outcome: a route and information checklist02
Documentation
We prepare or refine the description, operating documents and labeling, and clarify translation needs.
Outcome: consistent information03
Testing and manufacturing
We define tests and samples and coordinate testing and inspection.
Outcome: supporting evidence04
Complete dossier
We assemble the documents and verification materials and check versions and specifications.
Outcome: a submission-ready package05
Expert review and recognition
We support review in the reference state and recognition states.
Outcome: responses to requests06
Completion
We support the project through the competent authority's decision and verify the registration details.
Outcome: EAEU registrationWhy clients choose us
Registration without detours and lost months
We do not sell template packages. Every project starts with analyzing the device, so the documents pass the expert review and cause no problems after registration.
We read the dossier like an expert
Our team includes test engineers. They find discrepancies before submission, not after Roszdravnadzor remarks.
We write documentation from scratch
No specifications or operating manual? We will develop them. Have them but with errors? We will refine them so that everything matches.
One expert from start to finish
One specialist runs your project. They coordinate with the manufacturer and laboratories and are always available.
Devices of any complexity
From dressings to anesthesia units, X-ray equipment and implants. More than 450 projects in 10 years.
Common rules, your own route
We consider destination countries, the manufacturer, intended use and document readiness, and agree on the registration and recognition sequence.
We connect specifications, documentation and verification results in a single dossier. We help coordinate the manufacturer and laboratories, support review and address requests.
Getting started
- Brief device description and intended use.
- Instructions or a technical description, if available.
- Manufacturer and intended destination countries.
After review, we identify missing information, define the scope and suggest the next step.
Questions and answers
What to discuss before starting
Brief answers to common opening questions.
How does EAEU registration differ from the national procedure?
The national procedure concerns circulation in Russia. An EAEU project takes account of the selected reference state and recognition states. We discuss the appropriate route based on the device and intended markets.
Do we need to select all five countries immediately?
We select countries based on your supply plans. The possibility and procedure for expanding to additional countries are assessed separately for the project.
Can we use existing documents and test reports?
We start by assessing them. We check their relevance to the device, compliance with the selected procedure, completeness and consistency. We then identify what can be used and what needs to be added.
Is a manufacturing inspection required?
We determine the need for and scope of inspection based on applicable requirements and device characteristics. If required, preparation is included in the project plan.
How long does registration take?
The timeline depends on the readiness of source materials, testing scope, inspection and review in the selected states. After analysis, we create a staged plan and identify timings dependent on laboratories and competent authorities.
Regulatory framework. The rules for registration and expert evaluation of medical device safety, quality and effectiveness were approved by EEC Council Decision No. 46 of 12 February 2016. We check current requirements and their applicability for each project.
Procedure overview on the EEC website ↗Trusted by
Chosen by those who cannot afford a mistake in the dossier
Developers of devices for military medicine, defense enterprises, Russian plants and manufacturers from China, Türkiye, Korea and Germany. Below are our partners and signed and sealed letters of appreciation.
Appreciation from the Burdenko Main Military Clinical Hospitalfor professionalism and contribution to the domestic medical industry
Talk at the Military Medicine of the 21st Century conferencethe conference is organized by the S. M. Kirov Military Medical Academy
Letters from VIKor, SigmaPharm, Implant Engineering and many othersThis list grows with every project. Signed and sealed letters are collected below on this page.
Our partners
Your device. Your markets. A clear plan.
We will discuss documentation, selected countries and technical questions, and propose a sequence of work for your project.
Discuss an EAEU project ↗- 15+engineers and specialists
- 10+ yearsof experience among our leading specialists
- 450+projects of any complexity
Have questions or need a consultation?
What would you like help with?
- We will look into your task and suggest where to start
- After the review we send a plan: stages, timeline and cost
- You talk directly to the specialist who runs the project