How much does it cost to register a medical device in Russia?

KREDO.TECH offers four cooperation formats. The Start plan has a fixed price of 300,000 ₽ for preparing the documentary part, the Basic plan starts from 800,000 ₽ with a total project cost of 2,150,000–2,850,000 ₽, and the Extended plan is 100,000 ₽ per month for a full turnkey cycle. Individual pricing is quoted on request after consultation.

What is the difference between the Start, Basic, Extended and Individual plans?

Start covers preparation of the documentary part for companies with their own testing resources. Basic adds laboratories and testing, logistics and Roszdravnadzor support. Extended adds process control at every stage with monthly payment, while Individual is designed for complex and international projects.

What determines the final cost of medical device registration?

The cost depends on the risk class of the medical device, the need for technical, toxicological and clinical testing, the scope of the technical documentation, Roszdravnadzor requirements, and the country of manufacture together with the need for international logistics.

Why do most clients choose the Basic plan?

According to the article, Basic offers the optimal balance of control and delegation: it minimises errors without full outsourcing, keeps the process managed without overloading the internal team, and reduces risk at a reasonable cost.

KREDO.TECH Pricing

Cost of Medical Device Registration in Russia and EAEU

Pricing for medical device registration support: from document preparation to full turnkey registration

Unified Support Ecosystem: document preparation, testing organization, sample logistics and regulatory interaction until the registration certificate is obtained.

reduced risk of Roszdravnadzor rejection

30–50% faster registration timeline

single point of accountability

transparent regulatory process

Which format suits you?

🟦

I'm just getting started

need a starter document package
want to understand the registration route

👉 Start

🟨

I want a managed registration

I have a device / documents
need to register without errors and delays
need control without losing oversight

👉 Basic (most popular)

🟥

I want to hand off the entire process

no internal resources to manage
need a full turnkey cycle

👉 Extended

⚫

Complex or non-standard project

international / portfolio
high regulatory complexity

👉 Individual

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

Start

300 000 ₽

fixed price

Preparation of the documentary part for registration. Suitable for companies with their own testing resources.

✓ Documents
✗ Laboratories & testing
✗ Logistics
✗ Roszdravnadzor support
✗ Process control

Basic

from 800 000 ₽

total 2,150,000–2,850,000 ₽

★ Recommended

Full managed registration support: documents, testing, logistics and Roszdravnadzor interaction.

✓ Documents
✓ Laboratories & testing
✓ Logistics
✓ Roszdravnadzor support
✗ Process control

Extended

100 000 ₽/month

full turnkey cycle

Full registration cycle with monthly payment and continuous control at every stage.

✓ Documents
✓ Laboratories & testing
✓ Logistics
✓ Roszdravnadzor support
✓ Process control

Individual

Upon request

complex and international projects

For non-standard and international projects. Individual approach, pricing after consultation.

✓ Documents
✓ Laboratories & testing
✓ Logistics
✓ Roszdravnadzor support
✓ Process control

Plan Comparison

What's included	Start	Basic	Extended	Individual
Documents	✓	✓	✓	✓
Laboratories & testing	—	✓	✓	✓
Logistics	—	✓	✓	✓
Roszdravnadzor support	—	✓	✓	✓
Process control	—	—	✓	✓

★ Recommended

Why most clients choose the Basic plan

optimal balance of control and delegation

error minimization without full outsourcing

managed process without overloading the team

risk reduction at a reasonable cost

We'll help you choose the right plan

Answer the bot's questions and get a recommendation

do you have documents
do you have an internal team
do you need full control

👉 Launch Telegram Bot

What affects the cost of medical device registration

The cost of medical device registration depends on:

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

Ready to accelerate your device registration?

We'll provide a free documentation audit and suggest the optimal registration route for your specific device.

Frequently asked questions

How much does it cost to register a medical device in Russia?: KREDO.TECH offers four cooperation formats. The Start plan has a fixed price of 300,000 ₽ for preparing the documentary part, the Basic plan starts from 800,000 ₽ with a total project cost of 2,150,000–2,850,000 ₽, and the Extended plan is 100,000 ₽ per month for a full turnkey cycle. Individual pricing is quoted on request after consultation.
What is the difference between the Start, Basic, Extended and Individual plans?: Start covers preparation of the documentary part for companies with their own testing resources. Basic adds laboratories and testing, logistics and Roszdravnadzor support. Extended adds process control at every stage with monthly payment, while Individual is designed for complex and international projects.
What determines the final cost of medical device registration?: The cost depends on the risk class of the medical device, the need for technical, toxicological and clinical testing, the scope of the technical documentation, Roszdravnadzor requirements, and the country of manufacture together with the need for international logistics.
Why do most clients choose the Basic plan?: According to the article, Basic offers the optimal balance of control and delegation: it minimises errors without full outsourcing, keeps the process managed without overloading the internal team, and reduces risk at a reasonable cost.