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RegMedGrupp medical solutions
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17 years of regulatory expertise

Medical Device Registration
turnkey

Roszdravnadzor and the EAEU: from dossier and testing to the registration certificate. 1000+ certificates and not a single refusal since 2019.

Government Decree No. 1684 EEC Council Decision No. 46 Classes 1, 2a, 2b, 3
Assessment within 24 hours All services
4.9 / 5 · 230+ reviews 5 EAEU countries
100%
expert evaluation pass rate
since 2019
Project № 2026-1247
Device type Biochemistry analyzer
Risk class 2а
Jurisdiction Russia and the EAEU
Stage Expert review
Dossier readiness 78%
24 h
regulatory
assessment
Regulators and standards
ROSZDRAVNADZOR MINISTRY OF HEALTH OF RUSSIA EEC · EAEU TsMIKEE VNIIIMT GOST ISO 13485
Services · 01

Every registration stage is our responsibility

Six practice areas, from device classification to the registration certificate.

01 · FLAGSHIP

Turnkey registration dossier

A complete document set under RF Government Decree No. 1684 and EEC Council Decision No. 46: operational documentation, safety justification, ISO 14971 risk management.

Classes 1, 2a, 2b, 3 Russia and the EAEU All device types
02

Consulting and preliminary examination

Document audit, risk class and device type code, registration strategy.

Learn more
03

Development and execution of documentation

Specifications, manuals, risk management file, medical software validation.

Learn more
04

Organization and support of tests

Laboratory selection, technical and clinical trials, toxicological studies.
05

Preparation for production inspection, QMS, certification

Implementation of QMS from scratch, production audit, ISO 13485, CE marking.
06

Formation of dossier and state registration

Filing via the state services portal and liaison with Roszdravnadzor for devices of all risk classes.
All services
Geography · 02

We support manufacturers in 6 countries

ISO 13485 audits, production inspection readiness and authorized representation of foreign manufacturers in Russia.

EQUATOR · 0° + TROPIC OF CANCER Moscow Shenzhen Berlin Milan Tel Aviv Boston N AMERICA S AMERICA EUROPE ASIA AFRICA AUSTRALIA N 90° S 90° W 180° E 180°
FILE · 001 / 006 INSPECTION CONFIRMED
Moscow MOSCOW · 55.75°N

Russian Federation

Projects since 2009
1000+
Focus
Registration with Roszdravnadzor and in the EAEU

Head office: liaison with the regulator, test coordination, expert review support.

Shenzhen 深圳 · 22.54°N

People's Republic of China

Manufacturing inspections
200+
Focus
IVD and active devices

The main manufacturing region for electronics and IVD devices destined for the Russian market.

Berlin BERLIN · 52.52°N

Federal Republic of Germany

QMS audits
50+
Standards
ISO 13485 · EU MDR · ISO 14971

We adapt European MDR dossiers to Russian and EAEU requirements.

Milan MILANO · 45.46°N

Italian Republic

ISO 13485 projects
40+
Focus
Implants and cardio devices

We also work with small manufacturers.

Tel Aviv תל אביב · 32.08°N

State of Israel

Clinical studies
30+
Focus
SaMD and AI diagnostics

We register medical software and AI diagnostic systems by Israeli developers in Russia.

Boston BOSTON · 42.36°N

United States of America

Projects with FDA documentation
25+
Focus
FDA dossier adaptation

We prepare devices already cleared for the US market for registration in Russia.

RegMedGroup presence map

Results · 03

17 years of experience in one of the most heavily regulated industries

Updated quarterly from the Roszdravnadzor register and project statistics.

1000+
Registration Certificates
17
years on the market, since 2009
0
registration rejections since 2019
24h
to regulatory opinion
5
EAEU countries where we register devices
Process · 04

A transparent path from application to Registration Certificate

Seven stages with fixed deadlines, checkpoints and a dedicated project manager.

Get a plan tailored to your device
01

Questionnaire and regulatory opinion

Risk class, registration route (Russia or the EAEU), dossier composition, timeline and cost.

24 hours Free of charge
02

Dossier audit and technical specification

We review the existing documents and fix the price, timeline and deadlines. No hidden fees.

2–5 days No prepayment
03

Preparation of operational documentation

Technical specifications, passport, instructions for use, test programme in line with GOST R and EAEU requirements.

4–6 weeks ISO 14971
04

Technical testing

Performed in accredited laboratories: we follow the test reports, resolve non-conformities and arrange repeat testing when needed.

8–12 weeks Rosaccreditation
05

Toxicology testing

Biocompatibility: cytotoxicity, sensitisation, irritation, systemic toxicity.

6–10 weeks ISO 10993
06

Clinical trials

Analysis and evaluation of clinical data with a final report. Trials involving human subjects are planned separately.

4–8 weeks
07

Expert review support

We respond to expert queries, refine the documentation and see the project through to the registration certificate.

Until the certificate is issued
Case studies · 05

Registrations we have completed

Projects of 2024–2025: from diagnostic equipment to class III implants.

Implants Class 3 risk

Registration of a risk class 3 neuromodulator

Registration certificate issued without a single request for revision.

0
rejections
Equipment Class 2b risk

Registration of a class IIb X-ray system

Registration certificate obtained in 6 months.

0
rejections
Medical software (SaMD) Class 2a risk

Registration of an AI system for analysis of chest CT scans

Registration certificate obtained for AI-based medical software.

0
rejections
All cases
Comparison · 06

Why clients choose us over general-practice lawyers

Medical device registration is a narrow specialisation. Compare the approaches.

Criterion
General-practice lawyers
RegMedGrupp
Specialisation
Various industries
17 years, medical devices only
Registration term
12+ mo
7–8 mo
Expert review support
Under a separate contract
Until the certificate is issued
Timeline and price
May change as the work progresses
Fixed in the contract
Questions · 07

Frequently asked questions

Did not find the answer? Ask in the form below and we will reply within 24 hours.

Yes. We analyse the reasoned refusal, address the remarks and resubmit the application. Since 2019 every such project has ended with a registration certificate.
The timeline and stages are fixed in the contract. If a repeat review cycle is needed through our fault, we pay for it ourselves. There is no subscription fee after the certificate is issued.
On average registration takes 7–8 months; for class III it is longer: 12–14 months under the national rules (RF Government Decree No. 1684) and 14–18 months under the EAEU rules (EEC Council Decision No. 46). We state the exact timeline in the assessment.
Documentation audit, development of technical specifications and operational documentation, test organisation, application filing and expert review support. State fees and laboratory charges are separate lines in the estimate. All stages and amounts are fixed in the contract before work starts.
We specialize in complex and innovative products (software, AI, implants). 0 failures since 2019. We work directly with global manufacturers. You are leading a project with a specific expert, and not with a manager “for communication”.
One contract instead of 4–6 separate contracts. Single responsibility for the result, and not “everything is fine with us - complaints about the laboratory.” The deadline until RU is fixed once, without jumping between contractors.
Products of 1, 2a, 2b, 3 classes according to RF PP No. 1684. Focus - 2b and 3 classes: active implants, SaMD, IVD, life support equipment, where examination requires a methodological approach.
Yes. Full registration cycle for foreign manufacturers, including the functions of an authorized representative (APR) in the Russian Federation. Experience working with manufacturers from the EU, Asia and other regions.
Regulatory assessment · 08

Assessment for your device within 24 hours

We'll name the risk class, choose national or Eurasian route, list required tests and time to certificate.

  • Free assessment
  • Fixed price under the contract
  • Support until the certificate is issued

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