Medical device registration
Which medical devices are subject to mandatory registration?
Under the current legislation of the Russian Federation and EAEU regulations, medical devices may be placed on the market only after their quality, effectiveness and safety have been confirmed through the state registration procedure.
The following categories and types of medical devices are subject to mandatory registration with Roszdravnadzor:
The following categories and types of medical devices are subject to mandatory registration with Roszdravnadzor:
- Surgical and aesthetic medicine equipment and instrumentsMedical devices and powered instruments intended for invasive surgical procedures, minimally invasive interventions and therapeutic aesthetic procedures.
- Diagnostic equipment and imaging systemsComplex medical equipment for radiological, ultrasound and functional diagnostics, including ultrasound systems, X-ray systems, computed tomography (CT) and magnetic resonance imaging (MRI) scanners.
- In vitro diagnostic (IVD) medical devicesSpecialized reagents, calibrators, control materials, test systems, kits and automated analyzers used to examine human biological specimens outside the living organism.
- Medical laboratory equipmentTechnical instruments and automated systems intended for general clinical, biochemical, hematological, immunological and microbiological testing.
- Technical aids for medical rehabilitationEquipment and devices designed to restore impaired body functions, including robotic mechanotherapy systems, orthoses, exoskeleton components and specialized wheelchairs.
- Therapeutic equipment and devicesPhysiotherapy and specialized treatment equipment intended to provide direct therapeutic effects on tissues and body systems in order to manage pathological processes.
- Dental equipment and materialsDental units, therapeutic and surgical instruments, as well as filling, impression and auxiliary dental laboratory materials.
- Life-support medical devicesResuscitation and high-technology systems, including mechanical ventilators, anesthesia and respiratory systems, and extracorporeal membrane oxygenation (ECMO) systems.
- Implantable medical devicesMaterials, structures, endoprostheses and active devices intended to partially or fully replace anatomical structures and to be implanted in human tissues or body cavities.
- Consumables and other medical-use productsSyringes, injection needles, catheters, drains, dressings, surgical sutures and other single-use or reusable components used in patient care.
- Software as a medical device (SaMD)Specialized software and digital products used to process diagnostic data, monitor a patient’s condition or automate treatment processes.
Registration Procedure
The registration algorithm and depth of review depend directly on the device’s potential risk class (Classes 1, 2a, 2b and 3).
The procedure for obtaining a Registration Certificate (RC) follows two different pathways:
The procedure for obtaining a Registration Certificate (RC) follows two different pathways:
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For Class 1 devices and in vitro diagnostic (IVD) devices, all testing (technical, toxicological and clinical) is completed before submission to Roszdravnadzor. The dossier is reviewed in a single stage. - For Class 2a, 2b and 3 devices, the procedure is strictly divided into two stages of expert review.
Algorithm for Classes 2a, 2b and 3
Preparatory stage and documentation development
Determine the risk class; develop Technical Specifications (TU) for Russian-made products or compile the Technical File for imported devices.
Initial testing
Organize and control technical and toxicological testing in accredited laboratories and obtain official test reports.
Compilation and submission of the registration dossier
Assemble the complete document package and submit it to Roszdravnadzor for review.
Stage I of the state expert review
Documentary review of the dossier and quality assessment.
Authorization and conduct of clinical trials
Obtain Roszdravnadzor authorization to conduct clinical trials, strictly after successful completion of Stage I.
Stage II of the state expert review
Assessment of the clinical trial results by the expert organization.
Issuance of the registration certificate
The authority makes its final decision and enters the medical device in the State Register.
Frequently asked questions
The required documents depend on the device risk class and on the registration route (national registration or EAEU registration). The basic package includes a technical description, instructions for use, test reports covering biological, technical and clinical safety, the application, a copy of the agreement with the manufacturer and other documents. We determine the exact list individually after reviewing the device.
Yes. We are part of the Electrontest Group, which includes accredited laboratories for technical testing, biological safety testing and clinical studies for IVD devices. This allows us to accelerate the process and control quality at every stage.
The cost is calculated individually and depends on the device risk class, the need for testing, the complexity of the technical documentation and the scope of work (full-cycle support or support for individual stages). We provide a transparent stage-by-stage quotation with no hidden charges.
We provide services for amending the registration dossier and/or Registration Certificate, including changes to the manufacturer or address, updates to composition or technical characteristics, and expansion of indications for use. Depending on the type of change, the procedure may be conducted either with or without expert review.
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.
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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