Services
Registration of Medical Devices
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Official Inquiry to Roszdravnadzor Registration Dossier Development Medical Device Testing Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Quality Management System
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Intellectual Property
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Dietary Supplement Registration Product Certification & Declaration Product Certification Exemption Letter Construction Materials Testing Fire Safety Compliance Certification for Products
Licensing
Medical Activity License in Russia Medical Equipment Maintenance License in Russia
Pricing Reviews About Us FAQ Contact Us
Services
Registration of Medical Devices
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Official Inquiry to Roszdravnadzor Registration Dossier Development Medical Device Testing Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Quality Management System
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Intellectual Property
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Dietary Supplement Registration Product Certification & Declaration Product Certification Exemption Letter Construction Materials Testing Fire Safety Compliance Certification for Products
Licensing
Medical Activity License in Russia Medical Equipment Maintenance License in Russia
Pricing Reviews About Us FAQ Contact Us
+7 981 940 28 59
Every day from 9:00 a.m. to 6.00 p.m.
(time zone UTC+3 MSK)
Русский English
English
Русский

Registration of Medical Devices

Our principal activity area includes services, related to the circulation of medical devices
Our manager
will email you
Registration of medical devices - Glucometer

Our Advantages

Project Implementation
on a Turnkey Basis
Working with
Clients Worldwide
Regular Work Progress
Reporting
Provision of the Data
on Legal Framework
Changes
15
Years of Specialist Experience
in Medical Device Regulation
100%
Information Security &
Total Process Transparency

Our Services

01
Medical Device Registration
Registration of Medical Devices
More Details
02
ISO 13485 QMS Implementation and Certification for Medical Device Manufacturers
Quality Management System
More Details
03
Intellectual Property Protection for Medical Device Manufacturers: Inventions, Patents, Trademarks
Intellectual Property
More Details
04
Dietary Supplement Registration | Full-Service Solution for Brands
Dietary Supplement
Registration
More Details
05
Product Certification and Declaration of Conformity Services
Product
Certification
& Declaration
More Details
06
Product Certification Exemption Letter for Wildberries, OZON, and Other Marketplaces
Product Certification
Exemption Letter
More Details
07
Professional construction materials testing in a certified laboratory
Construction Materials
Testing
More Details
08
Fire Safety Certification Products
Fire Safety Compliance
Certification for Products
More Details
09
Licensing for Medical Activities and Medical Equipment Maintenance
Licensing
More Details
Select a Service
Medical Device Registration in Russia Medical Device Registration in EAEU Registration Dossier Amendments Cancel Medical Device Registration Registration Dossier Development Medical Device Testing Official Inquiry to Roszdravnadzor Authorized Representative (AR) Services for Medical Devices in Russia & EAEU
Select a Service
QMS Development & Implementation for Medical Devices in Russia & EAEU QMS Inspection Support for Medical Device Manufacturers QMS Certification Assistance for Medical Device Manufacturers
Select a Service
Trademark Registration in Russia & International Invention Registration in Russia Utility Model Registration in Russia Software Registration in Russia Copyright
Select a Service
Medical Activity License in Russia Medical Equipment Maintenance License in Russia

Pricing & Plans

Russian Registration
(National Rules)
EAEU Registration
(Customs Union)
Russian Registration
(National Rules)
RISK CLASS 1
from $4 900
RISK CLASS 2a
NON-STERILE PRODUCTS
from $6 750
RISK CLASS 2a
STERILE PRODUCTS
from $7 950
RISK CLASS 2b
from $9 800
RISK CLASS 3
from $11 650
EAEU Registration
(Customs Union)
RISK CLASS 1
from $6 750
RISK CLASS 2a
NON-STERILE PRODUCTS
from $9 200
RISK CLASS 2a
STERILE PRODUCTS
from $10 430
RISK CLASS 2b
from $12 270
RISK CLASS 3
from $14 110

Medical Device Registration:
Cost Breakdown

01
Preparation of Registration
Dossier Documents and
Registration Process Support
02
Medical Devices
Testing
03
Inspection of Medical
Devices Manufacturing
04
State Duties

Work Stages

01
Service Requests
Handling

Submit your service request and a brief description of the medical device

We assess your case and prepare a personalized commercial proposal

02
Contract
Execution

We execute a service agreement with You

We provide a tailored list of documents required for medical device registration

03
Consultation &
Analysis

Provide your existing documentation (technical files, certificates, etc.)

We assess their compliance with requirements and provide recommendations

04
Documentation
Preparation

We compile the complete set of documents for the registration dossier (technical and operational documentation, etc.)

We provide details on required sample quantities, testing costs, and a list of accredited laboratories to choose from

05
Organization & Support
of Necessary Testing

We submit the documentation and medical device samples to the testing laboratories/medical organizations selected by you

We oversee the testing process and provide full support

06
Inspection of Medical Device Manufacturing
Organization & Support

We assist in preparing the application, compiling necessary documentation, and executing the agreement with the inspecting authority

We select a qualified translator (for foreign manufacturers)

We provide real-time client guidance during regulatory inspections

07
Submission to the
Competent Authority

We submit the complete registration dossier
to the authorized body

We monitor the process and
promptly address all regulatory inquiries

08
Successful Registration
of Medical Devices
& Market Launch

Following successful review of the registration dossier, the authorized body makes the decision on medical device registration

We provide guidance on next steps (post-registration reporting requirements)

Customer Reviews

Thank You Letter from a Door Manufacturer for GOST Compliance Testing
Thank You Letter for Successful Medical Device Registration with Roszdravnadzor
Thank You Letter for Medical Device Registration Documentation Development for Roszdravnadzor
Thank You Letter for Fire Safety Certification of Fire-Resistant Curtains
Thank You Letter for Medical Device Registration
Thank You Letter for Registration Dossier Amendments
Thank You Letter for Medical Device Registration of the Multi-Band Ligator

Why Trust Us

Certificate of Advanced Training in Medical Device Production Localization in the Russian Federation
Employee Certificate of Participation in a Seminar on Medical Device Production Inspection
Employee Certificate of Participation in a Seminar on Clinical Trials of Medical Devices in the Russian Federation
Diploma of Professional Retraining in Medical Device Registration
Certificate of Advanced Training in Medical Device Production Inspection
Diploma of Professional Retraining in Medical Device Registration under EAEU Regulations
Employee Certificate | Internal QMS Audit Course
Employee Certificate | QMS Course - Requirements and Practical Application
Diploma of Professional Retraining in Medical Device Registration under Russian Regulations

Our Partners

About Us

NEEDFORMED LLC

Your expert regulatory consultant for medical device registration in Russia, Commonwealth of Independent States (CIS) and Eurasian Economic Union (EAEU) countries.

We help manufacturers and distributors bring their products to market across Russia, the Commonwealth of Independent States (CIS), and the Eurasian Economic Union (EAEU). We accelerate market entry while reducing regulatory risks, delivering the most efficient and cost-effective solutions for our clients.

We develop and implement Quality Management Systems compliant with the Interstate Standard (CIS Standard) GOST ISO 13485, which has been implemented as the Russian National Standard since June 1, 2018. This ensures the highest standards in medical device manufacturing and maintains stringent quality controls at all operational stages.

Additionally, we offer support in intellectual property, product certification and declaration, as well as obtaining licenses for medical activities and the maintenance of medical devices.

Ensuring Comfortable Cooperation
  • Online Meetings – we conduct consultations and meetings via secure platforms (Yandex.Telemost, Zoom, Microsoft Teams, etc.);
  • Offline Meetings in Moscow
    and St. Petersburg     – we organize in-person meetings to discuss your project;
  • Digital Document Workflow – we operate through cloud services with e-signatures for full legal validity;
  • Multilingual Support – communication in Russian, English, and Chinese.

We have proved that the quality of services depends not on the office address, but on the team expertise!

Why Choose Us
  • Flexibility – we adapt to our clients' time zones and working schedules;
  • Security – we utilize corporate VPNs and data encryption to ensure full confidentiality;
  • Transparency – we document all work stages and provide comprehensive reporting.
Cooperation Format

We operate on a «Cloud-Based Service» model:
Our team works entirely remotely without physical office constraints, leveraging advanced digital technologies for seamless collaboration.

This enables us to:

  • 24/7 Regulatory Inquiry Support;
  • Engage the best regulatory experts from different regions;
  • Reduce expenses and offer competitive conditions.
Entrust us with the regulatory and technical work
while you focus on growing your business!
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