Registration of medical devices according to the EAEU rules

Since 2017, it became possible to receive a registration certificate according to the rules of the Eurasian Economic Union (EAEU). KC-PROF was one of the first in the Russian Federation to provide a service for the registration of medical devices in accordance with the EAEU rules.

Benefits of receiving a registration certificate for medical devices according to the EAEU rules:

  • Registration certificates received in accordance with the rules of the EAEU are issued indefinitely and remain valid at the end of the transitional period, i.e. after 2021;

  • The validity of registration certificates received in accordance with the EAEU rules of the can be extended to other member states of the EAEU. At present, the EAEU includes the following member states: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic;
  • Registration according to the rules of the EAEU, in comparison with the registration according to the national rules (Russian Federation rules), imposes stricter requirements to medical devices and documents of the registration dossier. That is why having a registration certificate issued according to the EAEU rules is a serious competitive advantage in the medical devices market.

Registration of medical devices according to the EAEU rules on the territory of the Russian Federation is conducted by the Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor). In the process of the EAEU registration, Roszdravnadzor sends the registration dossier of a medical device to one of the subordinate organizations, FSBI VNIIIMT or FSBI NIK (formerly called FSBI CMIKEE), for quality, safety and effectiveness examination.

The procedure for registering medical devices according to the EAEU rules is regulated by the Decision of the Council of the Eurasian Economic Commission No. 46 “On the Rules for the Registration and Examination of the Safety, Quality, and Efficiency of Medical Products” dated February 12, 2016.

Registration of a medical device is carried out in 2 stages:
Stage 1 – preparation of documents required for registration of a medical device (documents of a registration dossier);
Stage 2 – registration and examination of a medical device.

STAGE 1 – preparation of documents

The completeness and accuracy of the documents of the output registration dossier are determined by multiple factors. The key ones we will discuss below. It is important to understand that the errors made at this stage can significantly increase the time and cost of registration and sometimes lead to a denial of registration.

Determining the risk class and the type of medical device in accordance with the nomenclature classification

In accordance with the Rules for the Classification of Medical Devices, all medical devices depending on their potential risk of application, are divided into 4 classes (the Rules are regulated by the Decision of the Eurasian Economic Commission No. 173 “On Approval of the Rules for the Classification of Medical Devices Depending on the Potential Risk of Application” dated December 22, 2015). The class of application risk to which a medical device belongs is one of the main criteria affecting the content of the registration dossier documents.

Compliance of the list of documents in the registration dossier to the required minimum

In addition to the class of potential risk of application, contents of the medical devices registration dossier are also determined by their type: the list of documents for products used for in vitro diagnostics has its own distinctive features.

Below we place a service which can help you receive an up-to-date list of registration dossier documents. In order to use it, select the risk class (1, 2a, 2b, 3) and type (in vitro, not in vitro) of your medical device in the drop-down list.

Unlike the registration by the Russian Federation rules, the EAEU rules require the inclusion of a risk analysis file for all products, including those of the 1st risk class.

At this stage, it is also possible to receive preliminary consultations from an expert organization on certain issues of registration and examination.

Collecting evidence of safety and effectiveness of a medical device

Once the list of registration dossier documents is determined, it is necessary to confirm compliance with the general requirements for the safety and effectiveness of medical devices, the requirements for their labeling and operational documentation (established by the Decision of the EEC Council No. 27 dated February 12, 2016). For these purposes, the Applicant conducts the following types of tests of medical devices:

  • technical tests;

  • testing (study) to assess the biological effects of a medical device;

  • tests for approval of the type of measuring instruments;

  • clinical trials (studies).

Technical tests are carried out in accordance with the Rules for Technical Testing of Medical Devices (the Rules are established by the Decision of the EEC Council No. 28 dated February 12, 2016).

Medical products for in vitro diagnostics (reagents, reagent kits) are not subject to technical testing.

Tests (studies) for the purposes of evaluating the biological effect of a medical device are carried out in accordance with the Rules for Conducting Studies (tests) for Evaluation of the Biological Effect of a Medical Device (the Rules are established by the Decision of the EEC Council No. 38 dated May 16, 2016).

Tests (studies) for evaluation of the biological effect are carried out only for the medical devices and (or) accessories for the medical devices that come into contact with the surface of the human body, its mucous membranes, and the internal environment of the body.

Tests for the approval of the measuring instruments type are carried out in accordance with the Procedure for the approval of the measuring instruments type (the Procedure is established by the Rules for the Approval of the Measuring Instruments Type valid on the territory of the Member States until the Decision of the Council of the Eurasian Economic Commission No. 98 ” On Approval of the Procedure for Approving the Type of Measuring Instruments” dated October 18, 2016).

These tests are carried out only for the medical devices classified as measuring instruments, the list of which is approved by the Commission (the List was approved by the Decision of the EEC Council No. 42 dated February 12, 2016).

The amount, terms and cost of studies (testing) of medical devices are determined by their specifications and, in particular, depends on their type (implantable or non-implantable; active or inactive; sterile or non-sterile; single-use or reusable; products for in vitro diagnostics, etc. ).

Clinical trials (studies) are carried out in accordance with the Rules for Conducting Clinical Trials (studies) of Medical Devices (the Rules are established by the Decision of the EEC Council No. 29 dated February 12, 2016) in authorized organizations selected by the applicant. Otherwise, the applicant includes medical devices with available clinical data into the registration dossier.

The applicant independently chooses the institutions and organizations where the above-mentioned types of tests are conducted. Please, remember that only certain laboratories and centers are suitable for these purposes. There is a unified register of organizations authorized to conduct trials (testing) of medical devices for the purpose of their registration on the territory of the EAEU.

Selecting a reference state and states of recognition

To register a medical device, the applicant should choose a reference state and, if necessary, register the medical device in several states of recognition.

According to the current regulatory documents, the Applicant should choose at least one state of recognition in addition to the reference state. Registration of the product on the territory of only one EAEU Member State (the reference state) is possible only if the expert organization of the recognition state does not agree on the expert opinion of the reference state.

Payment of state fees

After preparing the registration dossier, the applicant pays the fee for the examination and registration of the medical device in the reference state.
Fees for the examination and registration of a medical device in states of recognition are paid after the reference state arrives at a positive decision to register the medical device.
The cost of fees and payment procedure are determined in accordance with the laws of the Member States. In the Russian Federation, the amount of state fees is determined by the Tax Code of the Russian Federation.

STAGE 2 – registration and examination of a medical device

After the stage of preparing the documents, the actual examination and registration begin. For a visual display of this procedure, we prepared a chart divided into several successive steps. The diagram for each act contains explanations that appear in the tooltip when you point to the “+” icon.
The first step involves checking completeness and reliability of the documents submitted by the Applicant.


The manufacturer is a resident of one of the following states: the Kyrgyz Republic, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Russian Federation. Authorized representative of the manufacturer is a legal entity or an individual registered as an individual entrepreneur that resides in a member state and is authorized in accordance with the power of attorney of the medical device manufacturer to represent the interests of the manufacturer and bear responsibility for the circulation of the medical device within the EAEU and the fulfillment of the mandatory requirements for medical devices.

Reference state is a member state of the EAEU, the authorized body of which carries out registration of medical devices. State of recognition is a member state of the EAEU, the authorized body of which implements the procedure of approving the expert opinion of the reference state. The applicant, if necessary, can choose several states of recognition

The applicant should submit the following documents: 1. An application for the examination and registration of a medical device. 2. Registration dossier. 3. Copies of documents confirming the payment for the examination and registration of the medical device in the reference state selected by the applicant. Fees for the examination and registration of a medical device in states of recognition are paid after a positive decision is made on the registration of a medical device by a reference state

Within 5 working days from the date of receipt of the application and the registration dossier, the expert organization checks the completeness and accuracy of the information contained in these documents. The results of verification can be either positive - a decision is made to start the registration and examination of the medical device (the application and registration dossier are put into the database), or negative – if the application violates the requirements (contains false information, or the registration dossier is incomplete)

The Applicant has to eliminate the specified violations and (or) submit missing documents within a period of up to 30 working days

The Applicant is notified of the refusal within 10 working days from the date of arriving at the decision to deny registration of the medical device

If the application and the registration dossier comply with the requirements of the Rules of Registration and Examination (Decision No. 46 of the EEC Council dated February 12, 2016), the authorized body (expert organization) of the reference state arrives at a decision to start the procedure of the medical device examination and registration within 3 working days from the date of the dossier and application submission

At the end of the first step, the Applicant’s documents are submitted for examination. Simultaneously with the examination, the authorized body (expert organization) of the reference state conducts an inspection of the medical device production.


An authorized body (expert organization) or an organization appointed by an authorized body (expert organization) of the reference state inspects the production of medical devices. It is conducted before the expert opinion is developed. The inspection period is not included in the term of examination

The examination is conducted within 60 working days from the date of arriving at the decision to start the procedure of the medical device registration and examination

This stage is relevant if the examination of a medical device reveals shortcomings in the application for registration and in the documents of the registration dossier. In this case, the Applicant receives a request indicating the content of the remarks and recommendations on how to eliminate them. The period from the day of sending the request to the day of receiving the answer from the Applicant is not taken into account when calculating the examination period

The Applicant is notified of the refusal within 10 working days from the date of arriving at the decision to deny registration of the medical device

This request is sent to the Applicant in case of positive examination results. Within 10 working days, the Applicant should submit copies of the documents confirming the payment of registration and examination fees in the states of recognition

The start of registration and examination procedures requires confirmation of payment for the relevant procedures in the states of recognition

Inspection of the medical devices production is carried out before an expert opinion is developed.

The main part of the third step is the mutual approval of the reference state expert opinion by the states of recognition.


The reference state puts the expert opinion in the information system, which can be accessed by the authorized bodies (expert organizations) of the states of recognition

30 calendar days are calculated from the date when the authorized body (expert organization) of the reference state puts the expert opinion in its information system. If the states of recognition do not provide confirmation of approval (non-agreement) of the expert opinion within 30 calendar days, the expert opinion is considered approved. In the process of accepting an expert opinion, disagreements may arise. In this case, the authorized body of the reference state addresses the Advisory Committee on Medical Devices under the Board of the Commission for their settlement

Within 10 working days from the date of approval of the expert opinion by the recognition states, a decision is made to register the medical device and put it in the unified register (information about the medical device, user manual/instruction for use and the image of the approved labeling)

Within 10 working days from the date of the decision to register the medical device, a registration certificate (RС) and an annex to it are issued

In case of a positive result on the approval of the expert opinion, a registration certificate and an annex to it are issued.

Important aspects of registration according to the EAEU rules

Specifics of transitioning from the Russian Federation rules to EAEU rules

According to the current Decision of the EEC Council No. 46 dated February 12, 2019, the transition should be completed by December 31, 2021 (i.e. the validity of all registration certificates obtained under the rules of the Russian Federation is terminated). However, a legislative initiative is currently being prepared which will significantly simplify this transition as it will allow the registration certificates obtained during the registration according to the national rules of the EAEU member states to remain valid after December 31, 2021, and until their expiration, that is:

  • for the Russian Federation – indefinitely;

  • for the Republic of Kazakhstan – 5 years;

  • for the Kyrgyz Republic – indefinitely;

  • for the Republic of Belarus – 5 years;

  • no national registration procedure has been developed for the Republic of Armenia.

After December 31, 2021, registration of medical devices ‘from scratch’ according to the national rules of the EAEU member states will become impossible.

That is, if by the end of the transition period (as of December 31, 2021) the medical device will be undergoing one of the stages of the national registration procedure, the Applicant will be denied state registration due to the end of force of the national rules and the transition to the EAEU rules.
For this reason, we strongly recommend that our Clients step up those projects which are scheduled for registration in the near future in order to obtain a registration certificate according to national rules while it is still possible.

A detailed description of the registration procedure according to the Russian Federation rules and its features are given on the page devoted to registration according to Russian Federation rules.

Specifics of the amendment procedure for medical devices registered under national rules

After December 31, 2021, the procedure for amending the registration dossier of medical devices registered under the national rules will be conducted in accordance with the rules valid on the territory of the EAEU member states (i.e. national rules).

Specifics of the import of medical devices for the purposes of registration

As of now, there is no accepted regulatory document which would prescribe the import of medical devices for testing for the purposes of registration according to the EAEU rules (the Order of the Ministry of Health of the Russian Federation No. 7n, which is valid for the national registration procedure, applies only to the registration under the Russian Federation rules). Therefore, if the Russian Federation acts as the reference state and the medical device is tested in laboratories and centers of the Russian Federation, for a successful completion of customs procedures one needs to prepare an official letter to Roszdravnadzor (indicating information about the product under registration), with a power of attorney for an authorized representative of the medical device manufacturer attached to it. Hereafter, when going through the customs procedures, one uses the official response of Roszdravnadzor on the absence of necessity to issue an import permit (it is only necessary during the registration under the Russian Federation rules) as a document allowing unhindered import to the territory of the Russian Federation. In future years, the EEC plans to develop a document that will establish the procedure for importing medical devices for the purposes of registration in accordance with the EAEU rules.

Types of products subject to mandatory registration as medical devices:

Medical equipment:

  • Devices for cosmetology and surgery;

  • Diagnostic equipment (X-ray equipment, ultrasound equipment, etc.);

  • Analyzers and other laboratory equipment;

  • Complex technical rehabilitation facilities (electric wheelchairs, robotic prosthetics, etc.);

  • Life support equipment (artificial lung ventilation equipment, dialysis, etc.);

  • Therapeutic devices (ultrasound, radiofrequency treatment, etc.);

  • Dental units;

  • Implants;

  • Other equipment used for medical purposes.

Devices used for medical purposes:

  • Clothing, shoe covers, and other hospital-wide medical devices;

  • Consumables (reagents, replaceable filters, paper for electrocardiography, etc.);

  • Suture surgical material;

  • Bandages and other dressings;

  • Surgical instruments;

  • Inspection tools;

  • Medical furniture;

  • Orthoses;

  • Other products used for medical purposes.

Terms for receiving registration certificates for medical devices

The term for receiving a registration certificate depends on the risk class of the medical device, the chosen registration procedure, and the required amount of tests. Due to the fact that the registration procedure for medical devices in accordance with the EAEU rules involves more stages than the registration in accordance with the Russian Federation rules, the deadlines for the registration under the EAEU rules exceed the deadlines for the registration under national rules. The average terms are as follows:

  • Class 1 – 9-10 months;

  • Classes 2a and 2b – 10-12 months;

  • Class 3 – 12-15 months.

What you get if you choose us:

  • A personal expert who prepares the required documentation, all or in part, provides consultations on all issues related to the registration procedure and exercises control at all stages of the registration procedure of your product;

  • Reduced cost of registration since we help you to minimize its time, to avoid repeated submissions, and conduct testing and trials of your product on the most favorable conditions in partner organizations;

  • Direct partnerships with leading authorized laboratories and centers for preclinical and clinical trials, technical and toxicological tests, as well as with major healthcare institutions and medical associations. Therefore, you do not pay any extra cost for the mediation services;

  • Complete transparency of our decisions and actions aimed at obtaining results in the shortest time possible and at the lowest cost;

  • Convenient work procedure – you can receive services on a turnkey basis or use our help at a separate stage of registration indicated in the medical device registration chart from above;

  • A reliable assistant in all procedures related to the registration of medical devices (development of products ‘from scratch’, solving technical issues in their production, localization of production in the Russian Federation and many other issues);

  • Actual results instead of the promises that many other market participants make (especially those that are just mediators). That is why we offer our customers a “per-result” post-payment scheme.

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