Registration of Medical Devices under the EAEU Procedure: Legal Framework and Compliance Requirements in Russia

 

April 10, 2026

BRACE Law Firm ©

 

To form a common market for goods and simplify the procedures necessary for their circulation, the Russian Federation, along with Kazakhstan, Kyrgyzstan, Armenia, and Belarus, formed the Eurasian Economic Union (the "EAEU"). On December 23, 2014, the EAEU member states entered into the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union (the "Agreement").

In implementing this Agreement, the Russian Federation currently allows the circulation of medical devices that have undergone state registration either under the procedure provided by the Government of Russia or under the law of the Eurasian Economic Union (EAEU). Starting in 2028, it will only be possible to register medical devices under the EAEU procedure. [1]

This article examines in detail the rules for the registration of medical devices (the "medical devices", "MDs") in accordance with the EAEU procedure.

Which Medical Devices are Subject to Registration under EAEU Rules?

According to Article 2 of the Agreement, medical devices are any instruments, apparatus, devices, equipment, materials, and other products used for medical purposes, either alone or in combination with each other, as well as with accessories necessary for the intended use of these products (including special software), intended by the manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation, and monitoring of the human body, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the body, prevention or interruption of pregnancy, and the functional purpose of which is not realized through pharmacological, immunological, genetic, or metabolic effects on the human body, but may be supported by medicinal products.

According to Clause 5 of the Criteria for Classifying Products as Medical Devices within the Eurasian Economic Union, approved by Decision of the Board of the EEC No. 25 dated November 12, 2018, one of the primary criteria for classifying products as medical devices is the intended purpose of the medical device. The use of a medical device must provide for its medical purpose. Such medical purpose must be the sole or primary purpose.

As a general rule, medical devices released into circulation within the EAEU are subject to registration. Exceptions are established in Clause 11 of Article 4 of the Agreement, namely, medical devices imported for:

• personal use by individuals within the customs territory of the EAEU;
• manufacturing within the territory of a member state based on individual patient orders exclusively for personal use and which meet special requirements in accordance with the prescription issued by a healthcare professional;
• use by employees of diplomatic missions and consular offices;
• provision of medical care to passengers and crew members of vehicles, train crews, and drivers of vehicles arriving in the EAEU territory;
• provision of medical care to participants in international cultural and sporting events and participants in international expeditions, as well as for holding exhibitions;
• conducting research (tests), including for scientific purposes;
• humanitarian aid in cases determined by the legislation of the member states.

Thus, the vast majority of medical devices are subject to state registration.

Rules for the Registration of Medical Devices under EAEU Law

The registration of medical devices intended for circulation within the EAEU territory is carried out in the manner established by the Rules for the Registration and Expertise of the Safety, Quality, and Efficiency of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (the "Rules for Registration of EAEU MDs", "Decision No. 46").

Registration of a medical device may take place in one or several member states of the Union. According to Clause 2 of the Rules for Registration of EAEU MDs, "registration of a medical device" is the procedure for the issuance by the authorized body of the reference state of a permit for the release into circulation of a medical device in the territory of one or several member states.

The reference state is the member state chosen by the applicant, whose authorized body (expert organization) carries out the registration and expertise.

Additionally, when registering, the applicant chooses a concerned state – a member state whose authorized body (expert organization) carries out the procedure for coordinating the expert report of the reference state. The selection of two reference states is not permitted, but multiple concerned states may be chosen.

In each of the EAEU member states, there is a state body authorized to register medical devices. In the Russian Federation, this is the Federal Service for Surveillance in Healthcare (Roszdravnadzor); in other EAEU member states, it is generally the Ministry of Health.

A medical device registered under EAEU law must comply with the General Requirements for the Safety and Efficiency of Medical Devices, Requirements for their Labeling, and Operational Documentation for them, approved by Decision of the Council of the Eurasian Economic Commission No. 27 dated February 12, 2016. According to these requirements, medical devices must be effective and must be designed and manufactured such that, under normal conditions of operation, they correspond to the purposes of their intended use as defined by the manufacturer. During the design, manufacture, and packaging of medical devices, the risk created by pollutants must be minimized. In manufacturing a medical device, the risk of infection to users and third parties must be eliminated or reduced to an acceptable level. During state registration, the quality, safety, and efficiency of the medical device must be confirmed.

The authorized body issues the Registration Certificate for an indefinite term, and it remains valid within the territory of one or several member states.

The fact of state registration of a medical device is confirmed by a Registration Certificate. According to Clause 2 of the Rules for Registration of EAEU MDs, a "Registration Certificate" is a document of a uniform form confirming the fact of registration of a medical device in the territory of one or several member states.

Amount of the State Fee for the Registration and Expertise of a Medical Device under the Rules for Registration of EAEU MDs

A state fee must be paid for the registration and expertise of a medical device. Its amount is determined in accordance with the law of the reference state. It is possible to determine the amount of the state fee in a specific state through the electronic service provided on the official portal of common information resources and open data of the EAEU.[2]

In the Russian Federation, the fee is determined by Article 333.32.22 of the Tax Code of the Russian Federation. At the time of writing, it is:

• for the issuance of a Registration Certificate for a medical device – 11,000 rubles;
• for conducting an expertise of the safety, quality, and efficiency of a medical device depending on the class of its potential risk of use:
• class 1 – 72,000 rubles;
• class 2a – 104,000 rubles;
• class 2b – 136,000 rubles;
• class 3 – 184,000 rubles.

Furthermore, after the reference state makes a positive decision on registration, it will be necessary to pay a fee for the coordination of the expert report on the assessment of the safety, efficiency, and quality of the medical device in the concerned states. Its amount is determined in accordance with the law of that state. In the Russian Federation, it equals the state fee for conducting an expertise.

In addition to the state fee, tests and studies, as well as production inspections, are paid for separately. The cost of such tests and studies is calculated by the organizations authorized to conduct them.

Below is a detailed examination of the procedure for registering medical devices in accordance with Decision No. 46.

Pre-registration Procedures

To file an application for registration, several pre-registration procedures must be completed.

1. Determine the potential risk class and the nomenclature type of the medical device.

The potential risk class of a medical device is the class to which devices are assigned depending on the degree of potential risk of their use for medical purposes. Depending on the degree of potential risk of use, medical devices are divided into four classes:

• Class 1 – devices with a low degree of risk;
• Class 2a – devices with a medium degree of risk;
• Class 2b – devices with an increased degree of risk
• Class 3 – devices with a high degree of risk.

The rules for classifying a medical device by degree of risk are defined by Decision of the Board of the EEC No. 173 dated December 22, 2015.[3] When classifying an MD, the following are considered:

• the duration of use of the medical device;
• the invasiveness of the medical device;
• the presence of contact between the medical device and the human body or a connection with it;
• the method of introducing the medical device into the human body (through a body orifice or surgically);
• the use of the medical device for vital organs and systems (heart, central blood circulation, central nervous system);
• the use of energy sources.

Each medical device may be assigned to only one class. The established class is confirmed during subsequent pre-registration testing of the medical device.

The determination of the nomenclature type of a medical device is carried out based on the purpose and design of the device. For example, "orthopedic medical devices", "surgical invasive medical devices", "general hospital medical devices", etc. An electronic directory is available on the Portal of Common Information Resources and Open Data of the EAEU (the "Portal of Information Resources of the EAEU").[4]

2. Collect evidence of the safety and efficiency of the medical device.

To confirm compliance of the device with the General Requirements for Safety and Efficiency, it is necessary to conduct tests. Decision No. 46 provides for the following types of tests:

• technical tests;
• tests (studies) to assess the biological effect of the medical device;
• clinical and clinical-laboratory tests (studies);
• tests for the purpose of pattern approval of measuring instruments (regarding medical devices included in the list of types of medical devices classified as measuring instruments).

Technical tests of an MD are the determination of the quantitative and (or) qualitative characteristics of the properties of the test object as a result of the effect on it during its functioning, modeling of the object, and (or) effects on the object.

Technical tests are conducted in accordance with the Rules for Conducting Technical Tests of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 28 dated February 12, 2016 (the "Rules for Conducting Technical Tests of EAEU Medical Devices"). They are not required for reagents, reagent kits, control materials, calibrators, washing solutions, and culture media.

Technical tests may be performed by a test facility included in the unified register of authorized organizations entitled to conduct research (the "Register of Authorized Organizations"). The register is maintained by the Eurasian Economic Commission. It is available on the Portal of Information Resources of the EAEU. Specifically, in the Russian Federation, it includes the All-Russian Scientific Research and Testing Institute of Medical Engineering (VNIIIMT) of Roszdravnadzor and several other organizations.

To conduct tests, it is necessary to submit an application and a set of documents to the chosen test facility, enter into a contract, and provide samples.

The period for conducting technical tests is no more than 30 business days from the date the applicant provides samples and pays for the tests. The results of technical tests are documented in a Test Protocol.

Tests to assess the biological effect of a medical device are studies conducted to assess their biological safety. Tests are carried out only for medical devices that directly or indirectly contact the surface of the human body, its mucous membranes, or internal environments of the body.

Tests are conducted in accordance with the Rules for Conducting Research (Tests) to Assess the Biological Effect of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 38 dated May 16, 2016.

Like technical tests, biological safety tests may only be conducted by test facilities included in the Register of Authorized Organizations with the appropriate profile.

The tests include:

• determination of sanitary-chemical indicators;
• assessment of the biological effect in in vitro and in vivo conditions;
• microbiological tests (studies).

The period for conducting toxicological studies is 30 business days from the date samples of the medical device and the document package are provided, subject to payment for the tests. A test protocol is issued based on the results.

Clinical tests are tests (studies) involving a human subject conducted to study the safety and efficiency of a medical device.

Tests are conducted in accordance with the Rules approved by Decision of the Council of the Eurasian Economic Commission No. 29 dated February 12, 2016.[5]

A feature of such testing is that it requires obtaining a permit from the authorized body of the member state in whose territory they are planned to be conducted. In the Russian Federation, this body is Roszdravnadzor.

To obtain a permit, the manufacturer (its authorized representative) sends an application and a document package provided for by Annex No. 8 to Decision No. 26 to the authorized body.

Clinical tests are conducted in medical organizations (clinical centers) chosen by the applicant and included in the Register of Authorized Organizations.

Tests are carried out in accordance with the principles of the 1964 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, in accordance with the clinical test program. The purpose of such testing is to confirm the clinical safety and efficiency of the medical device.

Clinical tests for in vitro diagnostic medical devices are conducted in the form of clinical-laboratory tests. Clinical-laboratory tests are studies of analytical characteristics to confirm the compliance of the medical device with the purpose established by the manufacturer.

A Report is prepared based on the results of clinical tests

Tests for the purpose of pattern approval of measuring instruments are tests to determine the metrological and technical characteristics of an MD.

They are conducted only for medical devices classified as measuring instruments. The list of such medical devices was approved by Decision of the Council of the EEC No. 42 dated February 12, 2016.[6] It includes 15 groups of measuring instruments, such as thermometers, scales, tonometer, etc. Tests are conducted in accordance with the national legislation of the EAEU member state.

In the Russian Federation, tests are conducted by legal entities accredited in the field of ensuring the uniformity of measurements to perform tests of reference materials or measuring instruments with the appropriate scope of accreditation. Based on the results of the tests, a test report, a draft description of the pattern of the measuring instrument, and a verification methodology for the medical device are prepared.

Documents issued based on the test results are included in the registration dossier for the medical device.

3. Collect documents for the registration dossier.

A registration dossier is a set of documents and materials of a established structure submitted by the applicant when conducting registration and expertise procedures.

The list of such documents is provided in Annex No. 4 to the Rules for Registration of EAEU MDs and depends on the potential risk class of the medical device's use. We also recommend following the Guidelines on the Content and Structure of Registration Dossier Documents, approved by the Board of the Eurasian Economic Commission No. 27 dated December 23, 2024,[7] and the electronic service on the Portal of Information Resources of the EAEU when determining the necessary list of documents.

All the above procedures are carried out before filing the registration application, and the documents obtained from them are included in the registration dossier.

Stages of Registration of Medical Devices under the Rules for Registration of EAEU MDs

State registration of medical devices is carried out on an application basis by submitting a set of documents to the authorized body of the reference state.

The applicant may be the manufacturer of the medical device or its authorized representative. An authorized representative may be a legal entity or an individual entrepreneur who are residents of a member state and authorized by the manufacturer in accordance with a contract or another document to represent its interests and bear responsibility regarding the circulation of the medical device within the Union.

The applicant submits to the authorized body of the reference state:

• an application according to the forms in Annexes No. 2 and 3 to Decision No. 46;
• documents according to the list in Annex No. 4 to Decision No. 46;
• copies of documents confirming payment for registration and expertise procedures in the reference state.

Documents are submitted in electronic form. If the legislation of the member state does not provide for the possibility of issuing these documents in electronic form, they are provided in paper form.

The stages of registration are discussed below.

1. Document Verification.

Within 7 business days from the date the application and documents are received, the authorized body verifies the completeness and reliability of the information contained therein. If the information in the application or the document package is incomplete, the applicant is given 30 business days to eliminate the identified non-compliances. If the violations are not eliminated, a decision is made to return the filed application, stating the reasons.

If no violations are found, the authorized body makes a decision within 3 business days to begin the registration and expertise procedures and places the registration dossier in its information system.

Within 45 business days from the date the decision to begin procedures is made, the authorized body proceeds to the expertise of the medical device or, if a production inspection is necessary, issues a decision to begin the production inspection.

2. Production Inspection of Medical Devices.

Production inspection is an assessment of the production conditions and the quality management system of the medical device manufacturer. It is conducted in accordance with the Requirements for the Quality Management System, approved by Decision of the Council of the EEC No. 106 dated November 10, 2017.[8] During the inspection, the production itself, control, document management, and other processes are directly assessed.

Its conduct is mandatory for the registration of Class 2a medical devices released in sterile form, and Class 2b and Class 3 potential risk devices. For non-sterile Class 1 and 2a medical devices, the implementation of a quality management system and conducting an inspection are performed voluntarily.

The inspection may be conducted by an organization to which such powers have been delegated by the authorized body of an EAEU member state. The list of inspecting organizations is posted on the websites of the authorized bodies on the Internet and on the Union's information portal. In the Russian Federation, two organizations subordinate to Roszdravnadzor are authorized to conduct inspections: the National Institute of Quality (FGBU NIK) and the All-Russian Scientific Research and Testing Institute of Medical Engineering (FGBU VNIIIMT).

The maximum duration of an inspection is 90 business days. If necessary, the applicant is provided with no more than 60 business days to eliminate identified comments. The time taken for the inspection is not included in the expertise period.

A report on the results of the production inspection is sent by the inspecting organization to the authorized body of the reference state for inclusion in the registration dossier and to the applicant within 15 business days of its completion. If non-compliances are identified as a result of the inspection, the report is sent after receiving information from the applicant about the elimination of the non-compliances or after the expiration of the period established for their elimination.

3. Expertise of the Medical Device.

The expertise is conducted by an expert organization determined by the authorized body.

The expertise includes:

• assessing the correctness of classifying the product as a medical device;
• assessing the compliance of the potential risk class of use and the type of medical device specified by the applicant;
• assessing the possibility of including models (brands) of the medical device in one Registration Certificate based on the criteria established by Clause 19 of the Registration Rules;
• analysis and assessment of evidentiary documents (materials) for compliance with the General Requirements for Safety and Efficiency of Medical Devices;
• analysis of reports on the results of production inspections of the medical device and certification of the quality management system;
• analysis of data on the development and production of the medical device (flowcharts of production processes, information on the main stages of production, packaging, testing, and the procedure for releasing the final product);
• analysis of marketing information;
• analysis of information regarding the presence or absence of reports of adverse events (incidents), and a plan for collecting data on the safety and efficiency of the medical device at the post-market stage.

The period for the expertise is 45 business days from the date the decision to begin registration procedures is made. This period does not include the time for conducting a production inspection in cases where it is mandatory.

If the data is insufficient to prepare an expert report, the authorized body sends the applicant a corresponding request by the method specified in the registration application. The applicant must submit a response to the request within 60 business days of its receipt. If no response is submitted, the authorized body issues a decision regarding the possibility of registering the medical device based on the documents at its disposal.

Based on the results of the expertise, the expert institution prepares a report. A negative report is grounds for refusal of state registration. In such a case, the applicant is sent a notification justifying the reasons for the refusal, with a copy of the expert report attached.

4. Coordination of the Expert Report.

After receiving a positive expert report, the authorized body sends it for coordination to the authorized body of the concerned state.

Prior to this, the applicant must pay for and submit copies of documents confirming payment for the coordination procedure within 30 calendar days from the date the notification is sent by the authorized body. In addition, translations of the operational document, the service manual, and the labeling text into the state language of the concerned state must be submitted to its authorized body.

When conducting the coordination procedure, the authorized body of the concerned state assesses the completeness and sufficiency of the data confirming the safety, quality, and efficiency of the medical device, and the correctness of the document translations. The coordination period is 30 days from the receipt of the notification of payment for the coordination procedures.

Based on the results of the coordination, a report confirming the coordination (non-coordination) of the expert report is prepared. Coordination of the expert report is the basis for making a decision to register the medical device in the concerned state.

If there is no consensus on the coordination of the expert report, the resolution of disagreements may be carried out with the applicant's consent by the authorized body of the reference state applying to the EAEU Advisory Committee.

5. Decision on the Registration of a Medical Device.

Within 10 business days from the date of receiving confirmation of coordination of the expert report from all concerned states, the authorized body makes a decision to register the medical device and places information on the registration of the medical device in the Unified Register of Medical Devices Registered within the Union. Subsequently, within 10 days, the applicant is issued a Registration Certificate.

The Unified Register of Medical Devices is available on the Internet on the Portal of Common Information Resources of the EAEU. As of the date this article was prepared, it contains 63 entries of registered medical devices. In the vast majority of cases, the reference state was the Russian Federation or the Republic of Belarus. The spectrum of concerned states is broader, in some cases covering all members of the EAEU.

Grounds for Refusal of Registration of a Medical Device under the Rules for Registration of EAEU MDs

According to Clause 34 of Decision of the Council of the EEC No. 46, the grounds for the authorized body of the reference state to issue a report on the refusal of registration of a medical device are:

• failure to confirm the quality, and (or) efficiency, and (or) safety of the medical device by the corresponding materials and information contained in the registration dossier;
• the risk of causing harm to the health of citizens and medical workers as a result of the use of the medical device exceeding the efficiency of its use;
• the discovery by the authorized bodies during state control (supervision) of the circulation of medical devices of unreliable data on the efficiency and safety of the medical device and their non-compliance with the data on the medical device contained in the registration dossier documents.

Appealing a Refusal of State Registration of a Medical Device under the Rules for Registration of EAEU MDs

In accordance with Clause 10 of Article 4 of the Agreement on Uniform Principles for the Circulation of Medical Devices, a decision by the authorized body to refuse the issuance of a Registration Certificate for a medical device may be appealed by the manufacturer of the medical device or its authorized representative in court in the manner provided for by the legislation of that member state.

In the Russian Federation, such an appeal is made according to the rules of Chapter 24 of the Arbitration Procedure Code of the Russian Federation (APC RF), Challenging Non-regulatory Legal Acts, Decisions, and Actions (Inaction) of State Authorities. For the court to grant the application, the following circumstances must be proven in aggregate:

• non-compliance of the challenged decision, action (inaction) with the law or another legal act;
• violation of the rights and legitimate interests of the applicant in the sphere of entrepreneurial and other economic activity or the illegal imposition of any duties on it, or the creation of other obstacles to the conduct of entrepreneurial and other economic activity.

Since not many medical device manufacturers have yet completed registration under EAEU law, there is currently no judicial practice regarding issues related to registration under EAEU standards.

In conclusion, we note that the registration procedure under EAEU rules is more detailed in comparison with the procedure established by Russian legislation, and, at the same time, more complex in terms of conducting research and the presence of additional procedures for coordinating the expert report by the concerned state.

On the other hand, registering medical devices under EAEU rules allows for the free circulation of medical devices throughout the territory of the Eurasian Economic Union within the concerned states, which makes choosing this procedure more advisable.

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References

[1] Resolution of the Government of Russia No. 2214 dated December 30, 2025 On Amending Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024, and Applying Certain Provisions of the Rules for the State Registration of Medical Devices.

[2] See: https://portal.eaeunion.org/sites/odata/_layouts/15/Cit.Eec.Impop/Portal.Services/MedicalDevices/RegistrationSteps.aspx#step1.

[3] Decision of the Board of the Eurasian Economic Commission No. 173 dated December 22, 2015, On Approving the Rules for the Classification of Medical Devices Depending on the Potential Risk of Use.

[4] See the Information Portal of the Eurasian Economic Union: https://portal.eaeunion.org/sites/odata/_layouts/15/Cit.Eec.Impop/Portal.Services/MedicalDevices/ExamineDocs.aspx.

[5] Decision of the Council of the Eurasian Economic Commission No. 29 dated February 12, 2016, On the Rules for Conducting Clinical and Clinical-Laboratory Tests (Studies) of Medical Devices.

[6] Decision of the Council of the Eurasian Economic Commission No. 42 dated February 12, 2016, On Approving the List of Types of Medical Devices Subject to Classification as Measuring Instruments during their Registration.

[7] Recommendation of the Board of the Eurasian Economic Commission No. 27 dated December 23, 2024, On Guidelines on the Content and Structure of Medical Device Registration Dossier Documents and Conducting an Expertise of the Safety, Quality, and Efficiency of a Medical Device for the Purpose of its Registration within the Eurasian Economic Union.

[8] Decision of the Council of the Eurasian Economic Commission No. 106 dated November 10, 2017, On the Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of their Use.