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.
— 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.
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
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
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
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.
- ✓ Technical dossier review
- ✓ Registration feasibility analysis
- ✓ Compliance gap report
- ✓ Registration pathway plan
- ✗ Full registration management
- ✗ Testing and logistics
- ✓ Full technical dossier preparation
- ✓ Testing lab selection and coordination
- ✓ Sample logistics management
- ✓ Full regulator interaction
- ✓ Dedicated project manager
- ✓ Real-time progress tracking
We've compiled answers to the most frequently asked questions
about medical device registration
→ Go to FAQ
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.
LABBROKER.RU
@KREDO_AI_BOT
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.
