01Documentation
Description and instructions
Consistent documentation covering intended use, design, specifications, configuration, labeling and conditions of use.
Outcome: technical specifications, instructions and labeling
Under Russian national rules
Medical device registration in Russia
We prepare documents, arrange testing and run the dossier through to the Roszdravnadzor registration certificate. Test engineers check every detail before submission, so the expert review has fewer reasons for remarks.
A device description or instruction manual is enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
Documentation, testing and the dossier in one place
Four deliverables on the path to a registration certificate.
02Evidence
Test documentation
A testing plan, sample requirements, laboratory coordination and review of the resulting test reports.
Outcome: reports from accredited laboratories
03Completeness
Registration dossier
We check the document set, versions and consistency. Discrepancies are resolved before submission.
Outcome: a dossier ready for submission
04Ongoing support
Submission and responses
Support during review, responses to requests and comments, and preparation of clarifications.
Outcome: registration certificate
How registration works
Six connected stages. We determine the tests and any manufacturing inspection needed for your device.
01
Device analysis
We examine intended use, variants, composition and documentation.
Outcome: scope of work and required information02
Documents
We prepare or refine technical and operating documentation.
Outcome: a consistent document set03
Testing
We define tests and samples and coordinate laboratories and inspections.
Outcome: test reports04
Dossier
We assemble documentation and reports, checking completeness and versions.
Outcome: a dossier for submission05
Expert review
We support submission and review and respond to requests.
Outcome: responses and clarifications06
Decision
We support the project through to Roszdravnadzor's decision and check the register entry.
Outcome: registration certificateWhy 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.
The dossier as a consistent system
A registration dossier is a consistent system, not just a folder of papers. The device description, technical specifications, operating manual, test reports and application must agree. We review what you already have and identify what is missing for your procedure.
Why registration goes more smoothly with us
- Test engineers read the documents the way a Roszdravnadzor expert does and find discrepancies before submission.
- We write documentation from scratch or refine what you have. The specifications, operating manual and labeling take into account circulation in Russia and public procurement.
- One expert runs the project from the first conversation to the register entry and coordinates with the manufacturer and laboratories.
- You see the result of each stage and decide whether to continue.
Questions and answers
What to discuss before starting
Brief answers to common opening questions.
Can we start before all documents are ready?
Yes. A device description and the materials you already have are enough for an initial discussion. We will identify missing information and propose the documentation work required.
Which tests will be needed?
This depends on the intended use, design, materials and contact with the body. We determine the scope after a technical analysis. There is no single test list for every device.
National registration or the EAEU route?
The choice depends on the intended market and device characteristics. For a project targeting Russia, we consider the national procedure. Plans to enter other EAEU markets are discussed separately. Registration under EAEU rules
What happens if reviewers raise comments?
We analyze the request, compare it with the technical materials and prepare a response. Where needed, we clarify documentation or agree on additional work. Roszdravnadzor makes the registration decision.
Do you consider future deliveries and public procurement?
Yes. In preparing documentation, we develop the intended use, specifications, composition and configuration with future circulation in Russia and the customer's needs in mind, including public procurement.
Regulatory framework. The national procedure is governed by Russian Government Resolution No. 1684 of 30 November 2024. Requirements for technical and operating documentation are set by Russian Ministry of Health Order No. 181n of 11 April 2025. We check applicability for each project.
Current information from Roszdravnadzor ↗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
Let's start with your device
Tell us what you manufacture or plan to bring to market. We will discuss the available information, technical questions and the next step.
Discuss your 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