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  • Заголовок FAQ в блоке: Собрали для вас ответы на самые популярные вопросы о регистрации медицинских изделий
  • Заголовок FAQ на странице: Questions about medical device registration
  • FAQ:
    • Вопрос: What do you do that others don't?, Ответ:

      We don't just register devices — we design and manage the entire regulatory route: from strategy to the final certificate. Unlike the agency model, we build an architecture out of every component: logistics, laboratories, translations, deadline control, regulatory analysis.

      And most importantly — we do this using our own system of AI agents that replace manual chaos with algorithmic order. This isn't automation for speed's sake, but systemic thinking for the sake of accuracy and resilience. The result: fewer errors, higher reliability, more control, less time.

    • Вопрос: What is seamless registration and why does it matter?, Ответ:

      Seamless registration means the entire process is built as a single logical structure, with no gaps, no drop-offs, no manual patch-ups, and no losses at the handoff points.

      In the old model, documents are prepared by one team, testing is done by another, and logistics by a third — with no connection between them, and every step turning into a mini-crisis. With us, everything is connected: stages are planned in advance, processes run in parallel, and management logic is unified.

      Seamlessness means registration stops being a quest. It becomes a predictable trajectory with a guaranteed result.

    • Вопрос: Can you be trusted with mission-critical devices?, Ответ:

      These are exactly the devices we take on. We have no "economy class" and no "that's just how it has to be here." We work strictly to a standard of full transparency and legal integrity.

      The AI agents in our system check not only deadlines and templates, but also compliance with the actual requirements of technical regulations, verify laboratory accreditations, and flag errors before they ever make it into the dossier.

      That's exactly why we're trusted with complex, contentious, innovative, and sensitive devices — because we manage risks before they become problems.

    • Вопрос: What if you can't handle the volume?, Ответ:

      We're not building a department — we're building a system. Our infrastructure scales: new projects are added as processes within the operating platform. We calculate load in advance, reserve laboratory slots, and automate routine operations.

      Even when we have dozens of routes in progress, every project still gets personal support, while core actions follow a single unified standard.

      We don't overload people — we delegate part of the process to the system, and people focus only on what genuinely requires expert attention. That's how we grow without losing quality.

    • Вопрос: How does AI help with medical device registration?, Ответ:

      We've developed a model of AI agents where each "agent" isn't a generic chatbot but a narrowly specialized operator: for logistics, accreditation, document workflow, regulatory requirements, protocol verification, risk management.

      This system:

      • eliminates errors in the dossier,
      • flags supply chain disruptions before they happen,
      • verifies laboratories,
      • suggests the optimal route,
      • tracks legislative changes.

       This isn't a "helper module" — it's the nervous system of the entire project. Thanks to AI, we achieve what the manual market simply cannot: stability, speed, predictability.

    • Вопрос: We've already done almost everything ourselves. What can you offer?, Ответ:

      Great. Then we don't start from scratch — we plug into your current route. The KREDO system can connect at any stage: run an audit, reinforce weak links, finalize the dossier, replace a laboratory, organize logistics, and carry the project to the finish line without setbacks.

      You lose nothing at the start. You win at the finish. We're not replacing your work — we're completing it.

    • Вопрос: What makes you better than an experienced registrar who "does everything himself"?, Ответ:

      The fact that we don't depend on one person's memory, mood, connections, or workload.

      The KREDO system:

      • never forgets to account for new requirements,
      • never submits a protocol from a questionable laboratory,
      • never loses a document,
      • is never late with logistics,
      • never mixes up versions.

      We don't compete with good registrars. We offer them a tool that makes their work systematic, protected, and scalable.

    • Вопрос: How much does your work cost?, Ответ:

      We price the launch of the registration route, not a bundle of services. In other words, you don't pay for translations, deliveries, and brochures — you pay to pass every key point of the route correctly, on time, and within the law.

      We eliminate duplicate stages, unnecessary manual work, and unreliable contractors. That's exactly why KREDO often ends up cheaper than the traditional approach — especially once you factor in rework, losses, and "unexpected revisions."

      We don't have "vague estimates." We have a clear route, a fixed outcome, and transparent pricing.

    • Вопрос: What if we want to register hundreds of devices — can you handle it?, Ответ:

      Yes. KREDO was built for large-scale tasks. From the outset we designed the system to process entire device portfolios, build parallel routes, distribute workload, and manage several regulatory campaigns at once.

      We have solutions for large RA departments, corporate teams, and groups of companies. Everything scales — without losing control.

      We know how to work solo. But we're especially strong working alongside a client's own strong team.

    • Вопрос: Why do you believe the future belongs to your model?, Ответ:

      Because everything we do is a direct answer to the real costs of the manual market:

      • lack of transparency,
      • repeated errors,
      • lab bottlenecks,
      • outdated templates,
      • lost documents,
      • invalid protocols.

      We're building an architectural, technological, and scalable standard that the market will adopt as the new norm. Sooner or later, everyone will work this way. We simply started first.

      We're not just fitting into the regulatory system — we're helping rewrite its logic, language, and pace. If you're with us, you're inside this transformation. Not outside it.

  • Оффер:
    KREDO.TECH

    International Communications

    A digital ecosystem for the registration of medical devices under national regulations of the Russian Federation and the EAEU — fast, transparent, turnkey.

    • Knowledgeexpertise in logistics, testing, and medical device registration
    • Registrationfrom product samples to complete documentation within a unified ecosystem
    • Ecosystemincludes the LabBroker service and partner logistics companies
    • Documentationfast and error-free, using advanced technological solutions
    • Optimizationregistration processes on average 40% faster and more predictable
    Download the presentation:
    Consult an expert

    Conduct a self-audit of your documentation package online →

A Digital Ecosystem for Medical Device Registration | KREDO.TECH

Medical Device
Registration in Russia & EAEU

KREDOTECH accelerates medical device registration 1.5–2x through expert support, AI-powered document audit, trial coordination, and unified process management

We help manufacturers register medical devices in Russia and the EAEU:
from document analysis to obtaining the registration certificate.


What You Get:

  • Reduced rejection risk from Roszdravnadzor through preliminary AI audit
  • Shorter timelines through high-level expertise
  • Single point of accountability instead of multiple contractors
  • Transparent process and clear action plan

Medical Device Registration with Roszdravnadzor

— is a complex, multi-stage process governed by federal laws, Ministry of Health orders, and EAEU requirements.

KREDOTECH

— is not just a service or agency, but an intelligent system that transforms the very architecture of the medical device registration process in Russia and the EAEU.

Zoom Schedule Online Meeting

To bring a device to market, you need to:

  • undergo documentary review;
  • pass laboratory and clinical trials;
  • prepare an extensive set of documents;
  • and ultimately obtain the registration certificate.

We Transform the Medical Device Registration Process:

We provide a free initial document review, automate routine tasks using AI, offer a convenient service for selecting accredited laboratories, and assist with sample delivery — so your registration is faster, simpler, and with confidence in the outcome.

What's Happening in the Market

Medical device registration with Roszdravnadzor — a multi-stage regulatory process involving laboratories, logistics, and expertise

In practice, companies face:

  • Fragmented contractors
  • Document rejections from Roszdravnadzor
  • Unpredictable timelines and budgets
  • Complex stage coordination
  • Time lost to approvals

What KREDOTECH Does

Full-cycle medical device registration support

We consolidate the entire process into one managed pathway:

Documents & Dossier

  • Free AI audit of the initial package
  • Experts review and prepare the dossier
  • We reduce rejection risk

Testing

  • Selection of accredited laboratories via Labbroker
  • Experts review and prepare the dossier
  • Support for submission to Roszdravnadzor

Sample Logistics

  • Delivery across Russia and from abroad
  • Compliance with all regulatory requirements

KREDOTECH works with companies of any scale — from startups to international corporations. We complete registration quickly and without errors.

We also actively work with:

  • Distributors and brand representatives
  • In-house RA departments of large companies

How to Get Started

There are 2 ways to work with us:

Need Help with Your Case

If you already have a device and documentation:

  • We'll analyze your situation
  • We'll assess risks and timelines
  • We'll propose a registration strategy
  • We'll recommend the optimal plan
Get Consultation

Want to Understand the Format and Cost

If you're choosing a contractor:

  • Review our pricing plans
  • Compare support models
  • Choose your level of KREDOTECH involvement
View Pricing

Why It's Faster with Us

  • ✓Parallel execution of stages instead of sequential
  • ✓Preliminary AI analysis of documents
  • ✓Unified management of all contractors
  • ✓Fewer rejections from Roszdravnadzor
  • ✓Ready-made laboratory and logistics network

Result:
Medical device registration takes on average 30–50% less time.

How Working with KREDOTECH Works

  • 1Free document audit for medical device registration
  • 2Strategy and pricing plan formation
  • 3Sample logistics
  • 4Laboratory selection and testing
  • 5Dossier review
  • 6Submission to Roszdravnadzor and support through to registration certificate

Who Is It For?

  • Medical device manufacturers in Russia and abroad
  • Sellers and importers of medical devices
  • MedTech startups
  • Distributors and brand representatives
  • RA/QA departments of large companies
Get Consultation

WHAT MAKES UP THE PRICE

Medical Device Registration Cost:
Pricing Plans

The cost of medical device registration depends on:

  • the risk class of the medical device;
  • the need for technical, toxicological, and clinical trials;
  • the volume of technical documentation;
  • Roszdravnadzor requirements;
  • the country of manufacture and the need for international logistics.

Choose the cooperation format that best fits your project.
From basic document preparation to full turnkey support.

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Starter
from USD 2,500
one-time fee
Ideal for companies entering the Russian market for the first time who need to understand registration pathways and document requirements.
  • ✓ Technical dossier review
  • ✓ Registration feasibility analysis
  • ✓ Compliance gap report
  • ✓ Registration pathway plan
  • ✗ Full registration management
  • ✗ Testing and logistics

We've compiled answers to the most frequently asked questions
about medical device registration

→ Go to FAQ
We have built a unified digital ecosystem combining AI document audit, laboratory selection, sample logistics, and Roszdravnadzor support — all in one managed process under unified accountability.
Seamless registration means all stages — from initial document analysis to obtaining the registration certificate — run in parallel and without gaps, reducing the overall timeline by 30–50%.
Since 2019, we have successfully registered devices of all risk classes, including implants and diagnostic equipment. We work with manufacturers from Russia, Europe, and Asia.
Our platform scales to any volume — from a single device to hundreds in parallel processing. We work with large holdings and international manufacturers simultaneously without compromising quality.
The AI audit analyzes your document package for compliance with Roszdravnadzor requirements, identifies weaknesses and potential rejection causes before submission — allowing errors to be corrected in advance.
We can join at any stage: conduct an AI audit of completed documentation, organize testing, or take over final submission to Roszdravnadzor. You don't redo what's done — we work with what exists.
An experienced registrar is one person with limited time. We are a team of experts plus a digital platform: parallel task processing, automatic deadline control, and a single point of accountability.
The cost depends on the device's risk class, documentation volume, and required trials. The basic plan starts from 300,000 ₽. We will conduct a free audit and provide an exact cost after analyzing your project.
Yes. Our model was designed from the outset for high-volume registration. For large portfolios, we develop individual prioritization schemes and assign a dedicated support team.
The regulatory environment is becoming more complex, requirements are growing, and deadlines are tightening. The only answer is digital process automation. We are already doing today what the market will arrive at in 3–5 years.

Ready to Accelerate Your Device Registration?

We will conduct a free audit of your documentation and propose the optimal registration pathway tailored to your specific device.

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Frequently asked questions

What is seamless registration and why does it matter?
Seamless registration means all stages — from the initial document analysis to obtaining the registration certificate — run in parallel and without gaps, which reduces the overall registration timeline by 30–50%.
How does AI help in medical device registration?
The AI audit analyses your document package for compliance with Roszdravnadzor requirements and identifies weaknesses and potential causes of rejection before submission, so errors can be corrected in advance.
Can we trust you with critical devices?
Yes. Since 2019, devices of all risk classes have been registered, including implants and diagnostic equipment, and the company works with manufacturers from Russia, Europe and Asia.
We've already done most of it ourselves. What can you offer?
We can join at any stage: conduct an AI audit of the completed documentation, organise testing, or take over the final submission to Roszdravnadzor. You don't redo what is done — we work with what exists.
What if we want to register hundreds of devices — can you handle it?
Yes. The model was designed from the outset for high-volume registration; for large portfolios we develop individual prioritisation schemes and assign a dedicated support team.

See also

Expert insights on medical device registration
Regulatory updates, case studies and checklists — in our Telegram channel.
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