By the numbers
136
Dentistry
Dental devices and instruments
Implants
Neuromodulators, hyaluronic acid implants and other implantable devices
50
46
Urology
Urological catheters, stents, baskets, guidewires, sling systems, lithotripters and other devices
189
In vitro diagnostic devices
Analyzers, reagents, calibrators and control materials
General hospital devices
Hospital furniture, rehabilitation equipment, lamps, irradiators and other products
63
Registration certificates obtained
between
2013 — 2026
2013 — 2026
Large and complex equipment
X-ray systems, ventilators, operating tables, defibrillators and other equipment
94
201
Amendments to registration dossiers and certificates
Amendments to registration dossiers, with or without expert review, and amendments to Registration Certificates
Surgery
Surgical instruments
68
57
Other
Devices not included in the other categories
30
Cardiology
Cardiology stents, guidewires and other devices
935
Our services
Results are at the core of our approach
Our work is focused on achieving concrete outcomes while building long-term, mutually beneficial relationships with every client. We continuously monitor and carefully analyze changes in applicable regulatory requirements, allowing us to adapt quickly to new rules and expectations.
Our advantages
-
Deep expertise in medical device registrationWe work with medical devices of all risk classes, from simple products to high-risk ones. Our approach reflects Roszdravnadzor's current requirements and how expert reviews actually go in practice, which reduces the risk of comments and requests for revisions. -
In-house testing laboratoriesWe carry out technical, toxicological and EMC testing in our own facilities. This lets us avoid third-party organizations, shorten timelines and keep full control over the quality of results. -
End-to-end registration managementWe handle the development and revision of documentation, and we prepare and manage the registration dossier. We support the project through every stage of the expert review and, when needed, help introduce amendments to the registration certificate.
Work Stages
Initial audit
- Expert review of the technical documentation provided.
- Identification of regulatory requirements for the specific task.
Document preparation
- Development, revision and translation of operational documentation.
- Preparation of a turnkey document package.
Procedure management
- Coordination of the required tests and laboratory studies.
- Full expert support during the state expert review.
Completion and Handover
- Monitoring of data entry into state registers.
- Handover of the finalized forms and documents to the client.
Client testimonials
Отзывы наших клиентов
Xun Wei
General Director
We, Mindray Medical Rus LLC, would like to thank Resultat-Audit LLC for many years of productive cooperation, mutual understanding and the competent advice provided by your specialists. With your support, we have already registered more than 100 medical devices. All work was completed to a high standard and on time. We currently have more than 50 additional projects in progress and are confident that the work will continue to be handled professionally, efficiently and responsibly.
We, Biorad Medisys Pvt., would like to express our appreciation to Resultat-Audit LLC for its work on the state registration of medical devices and for more than three years of productive cooperation. All work has been completed efficiently and on time. We are satisfied with the company’s performance and recommend it as a professional partner. We are currently continuing work on several projects and are confident that our cooperation will remain responsible, efficient and results-oriented. We look forward to continuing our cooperation with your company.
Babu P. P.
Vice President
Мы, Biorad Medisys, выражаем благодарность Группе компаний «Электронтест» за выполнение работ по государственной регистрации медицинских изделий
и плодотворное сотрудничество на протяжении более 3 лет.
и плодотворное сотрудничество на протяжении более 3 лет.
Все работы были выполнены качественно и в срок. Мы довольны деятельностью группы компаний и рекомендуем её как профессионального партнёра.
В настоящее время мы продолжаем совместную работу по нескольким проектам и уверены, что работы будут продолжены также ответственно, качественно и эффективно.
We, Boston Scientific LLC, would like to express our appreciation for many years of productive cooperation, mutual understanding and the competent advice provided by your specialists. With your support, we have already registered more than 50 medical devices. All work was completed to a high standard and in a well-coordinated manner. We currently have more than 10 additional projects in progress and are confident that the work will continue to be handled professionally, efficiently and responsibly.
M. V. Boyarina
Authorized Representative
Мы, ООО «Бостон Сентифик», хотели бы выразить благодарность за многолетнее плодотворное сотрудничество, взаимопонимание и компетентные консультации, оказанные специалистами вашей компании.
C вашей помощью мы уже зарегистрировали более 50 медицинских изделий. Все работы были выполнены качественно и согласованно. На данный момент у нас в работе еще более 10 проектов, и мы уверены, что работа будет проходить также профессионально, оперативно и ответственно.
Frequently asked questions
Yes, provided the devices meet the applicable grouping criteria. Different models or modifications may be included in a single registration dossier and RC if they have the same intended purpose, a comparable principle of operation, the same manufacturer and belong to the same potential risk class. Grouping can substantially reduce the volume of documents to be collected and streamline the expert-review process. Resultat-Audit specialists will analyze your product range in detail and determine whether it can be registered under a single certificate.
Yes. We provide comprehensive services throughout the EAEU, including full support for state registration in the Republic of Belarus and the Republic of Kazakhstan. Our experts adapt technical files, instructions and related operating documentation to the current requirements of local ministries of health and expert organizations.
The risk class depends on the degree of impact on the human body and directly determines the complexity and composition of the registration dossier. For both general medical devices and in vitro diagnostic products such as reagents, calibrators and test systems, the regulatory frameworks of the Russian Federation and the EAEU provide for four potential risk classes: 1, 2a, 2b and 3. Incorrect classification at the outset is one of the main reasons regulators return documents, because the risk class affects the choice of accredited laboratories and the scope of clinical testing. Resultat-Audit experts perform a detailed preliminary audit of the technical documentation to determine the correct risk class for the product.
Whenever information about the product, its labeling or its manufacturer changes. Simple changes, such as a company-name change or a label-design update, may follow a simplified procedure. More substantial changes, such as adding new device modifications or a new manufacturing site, require mandatory state expert review of quality. Resultat-Audit will analyze the proposed updates and manage the procedure with minimum risk of disruption to ongoing sales.
News
Still have questions?
Submit a request and we will call you back within one hour, review your case and propose a solution.
Business hours
Weekdays: 9:00 AM – 6:00 PM
Saturday and Sunday: Closed
Saturday and Sunday: Closed
Contact us
Contacts
6 Klinskaya St., Office 212, Moscow
+7 495 455-11-16
Companies
Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.
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