Registration of medical devices

The DOCLINX team provides services for the registration of medical devices in the Russian Federation.

Why is state registration of medical devices necessary?

State registration is a mandatory procedure for any medical device planned for introduction to the Russian market. The circulation of unregistered medical devices entails serious consequences: fines, restrictions on activities, as well as administrative and criminal liability (according to Article 6.33 of the Administrative Code and Article 238.1 of the Criminal Code of the Russian Federation).

What are the classes of medical devices?

When classifying medical devices according to the degree of potential risk of use, four classes are distinguished:

• class 1 — medical devices with a low degree of risk;
• class 2a — medical devices with a medium degree of risk (non-sterile and sterile);
• class 2b — medical devices with an increased degree of risk;
• class 3 — medical devices with a high degree of risk.

When classifying medical devices, their functional purpose and conditions of use are taken into account, as well as the following criteria:

• duration of use;
• invasiveness;
• presence of contact with the human body or interaction with it;
• method of introduction into the human body (through anatomical cavities or surgically);
• application for vital organs and systems (heart, central circulatory system, central nervous system);
• use of energy sources.

How does the state registration of medical devices proceed?

State registration of medical devices is conducted based on the results of:

• technical tests;
• toxicological studies;
• clinical trials;
• examination of quality, effectiveness and safety;
• tests for the purpose of approving the type of measuring instruments*;
• inspection of the production site (for devices of potential risk classes 2a (only sterile), 2b and 3).

*in relation to medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation

Technical tests — tests to determine the compliance of the characteristics (properties) of a medical device with the requirements of regulatory documentation, technical and operational documentation of the manufacturer, and to make a subsequent decision on the possibility of conducting clinical trials.

DOCLINX provides services for organizing technical tests, developing test programs, and interacting with testing organizations.

Toxicological studies — studies to assess the biological safety of a medical device and make a subsequent decision on the possibility of conducting clinical trials.

DOCLINX provides services for organizing toxicological studies, developing research programs, and interacting with research organizations.

Clinical trials — a developed and planned systematic study undertaken, including with human participation as a subject, to assess the safety and effectiveness of a medical device.

DOCLINX provides comprehensive services for organizing clinical trials, including the selection of suitable healthcare facilities, development of research programs, selection of equivalent medical devices and compilation of an equivalence table, as well as selection of relevant scientific works and publications.

Examination of quality, effectiveness and safety - evaluation of the set of documents submitted for state registration.

Quality — the totality of properties and characteristics of a medical device that affect its ability to function as intended, provided that it complies with the requirements of regulatory documentation, technical and operational documentation of the manufacturer.

Effectiveness — the totality of properties and characteristics of a medical device that ensure the achievement of the intended purposes established by the manufacturer and confirmed by the practice of clinical application.

Safety — the absence of unacceptable risk of harm to life, human health and the environment when using a medical device for its intended purpose under the conditions provided by the manufacturer.

Production site inspections

Inspection is carried out by one of the subordinate institutions of Roszdravnadzor and includes a visit by inspectors to the production site. The DOCLINX team will ensure high-quality organization of the inspection process — from the initial contact with the inspecting organization to obtaining the final report.

Upon completion of all tests, studies and inspections, the DOCLINX team finalizes the package of documents for submitting the dossier to the registering authority.

Estimated timeline for the registration procedure

Medical device risk class	Estimated procedure duration, months
1	8-12
2a non-sterile	8-12
2a sterile	10-14
2b	10-14
3	10-14

Personalized commercial offerr

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Regulatory Acts

• Decree of the Government of the Russian Federation of November 30, 2024 No. 1684 "On Approval of the Rules for State Registration of Medical Devices"
• Roszdravnadzor Order No. 3371 dated 06.05.2019 "On Approval of the Administrative Regulations of the Federal Service for Surveillance in Healthcare for the Provision of State Services for State Registration of Medical Devices
• Order of the EEC Board dated 02.04.2019 No. 56 "On the Implementation of the General Process 'Formation, Maintenance and Use of the Unified Register of Medical Devices Registered within the Eurasian Economic Union'"
• Order of the EEC Board dated 12.11.2018 No. 176 "On the Implementation of the General Process 'Formation, Maintenance and Use of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Research (Testing) of Medical Devices for the Purpose of Their Registration'"
• Recommendation of the Board of the Eurasian Economic Commission dated December 23, 2024 No. 27 "On Methodological Guidelines for the Content and Structure of Medical Device Registration Dossier Documents and Conducting Safety, Quality and Effectiveness Evaluation of Medical Devices for Registration within the Eurasian Economic Union"
• Decision of the EEC Board dated 21.08.2018 No. 135 "On the Classifier of Types of Documents Issued During the Review of the Registration Dossier of a Medical Device"