State registration of medical devices in the Russian Federation
Experience with devices of all risk classes and levels of complexity.
Turnkey support at rvery stage
Experience working with all classes of risk and complexity
From dental instruments to CT/MRI systems and implants.
Technical and toxicological testing, as well as clinical testing of in vitro devices, within the Electrontest Group — without third-party handoffs or unnecessary delays.
In-house accredited laboratories
Our Advantages
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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.
Registration Stages
Product analysis and strategy development
Assessment of the medical device class, identification of the required types of testing and development of a step-by-step registration plan.
Import permit (for foreign-made devices)
Preparation of the permit to import the medical device into the Russian Federation for testing and subsequent registration.
Registration dossier development
Preparation of the complete set of documents: registration application, manufacturer technical documentation, operating documentation and information on the applicable regulatory documentation.
Organization of testing
Technical testing, toxicological studies and testing for type approval of measuring instruments in accredited Electrontest Group laboratories.
Clinical trials
Clinical trials at medical organizations accredited by Roszdravnadzor, followed by submission of the results.
Submission of the dossier to the registration authority
Submission of the registration dossier to Roszdravnadzor with support throughout all stages of the procedure.
Expert review of quality, effectiveness and safety
Review of the registration dossier documents by the expert institution.
Entry in the roszdravnadzor register and assignment of a unique registration number
The Registration Certificate is issued as an electronic register entry for the medical device. The Registration Certificate is valid indefinitely.
Documents we prepare
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State registration applicationOfficial application to Roszdravnadzor containing complete information about the device, applicant and manufacturer. - Information on regulatory documentationInformation on Technical Specifications, standards and regulatory documents under which the device is manufactured.
- Manufacturer technical documentationExtract from the technical file, risk management file, manufacturer reports and qualification test reports.
- Operating documentationInstructions for use, device passport, labeling and packaging — all in accordance with Russian Federation legal requirements.
- Technical testing documentsTest reports confirming safety, functionality and compliance with technical requirements; testing is performed by the accredited Electrontest LLC laboratory.
- Toxicological study documentsBiological safety reports, including microbiological, sanitary-chemical and toxicological studies performed by the ElectrontestBio LLC laboratory.
- Documents for type approval of measuring instrumentsTest results for medical devices classified as measuring instruments, prepared for type approval purposes.
- Clinical effectiveness documentsClinical trial reports, where required, or a justification for not conducting clinical trials, depending on the device class and legal requirements.
Still have questions?
Submit a request and we will call you back within one hour, review your case and propose a solution.
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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