Amending the Registration Dossier for Medical Devices under EAEU Rules: Legal Analysis of Procedures

 

April 22, 2026

BRACE Law Firm©

 

Pursuant to Article 38 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation, the circulation of medical devices in the Russian Federation is permitted if they are registered in the manner established by the Russian Government or in accordance with the acts constituting the law of the Eurasian Economic Union.

During the operation and manufacture of medical devices, situations arise that require amendments or additions to the registration dossier of the medical device. Furthermore, if a regulatory body identifies violations during the circulation of medical devices, it may suspend the registration or cancel the validity of the registration certificate.

However, amending the documents of the registration dossier (the "Amendments"), as well as the suspension and cancellation of the registration certificate, are administrative procedures subject to established requirements. The procedure depends on whether the manufacturer originally registered the medical device under (1) the national rules of the Russian Federation or (2) EAEU rules.

This article examines in detail the procedure for these processes carried out under EAEU law.

What Is Included in the Registration Dossier for a Medical Device under the EAEU Procedure?

Before examining the main topic, let us consider what a medical device registration dossier includes.

Registration dossier means a set of documents and materials submitted by the applicant during the procedures for registration and expertise, approval of the expert report, amending the registration dossier, approval of the expert report for a registered medical device, and cancellation (annulment) of the registration certificate of a medical device, as well as other documents related to a specific medical device. In particular, the registration dossier includes:

• Applications and other information about the manufacturer;
• Technical and operational documentation for the medical devices
• Data on labeling and packaging, and photographs of the medical device
• Test and research protocols;
• Reports on the results of production inspections;
• Decisions of regulatory bodies (expert organizations);
• Minutes of meetings of the Consultative Committee on Medical Devices, documents submitted during dispute resolution, etc.

The manufacturer must maintain the registration dossier in an up-to-date state. Manufacturing medical devices that do not comply with the documents in the registration dossier creates risks of the device being recognized as substandard or falsified. Consequently, manufacturers (or their authorized representatives) must initiate the Amendments procedure in a timely manner.

The Procedure for Amending the Registration Dossier under EAEU Law

The Rules for Registration and Expertise of the Safety, Quality, and Effectiveness of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (the "EEC Decision No. 46", or the "EAEU Rules"), regulate the procedure for amending the registration dossier under EAEU law.

According to Paragraph 66 of the EEC Decision No. 46, as a general rule, the manufacturer must initiate the Amendments procedure within 90 calendar days from the date of making changes to the documents contained in the registration dossier.

At the same time, the following changes fall under exceptions that require the registration of a new medical device

Changes that result in a change in the functional purpose and (or) the principle of operation of the medical device

Inclusion of information on models (marks) of a registered medical device that do not meet the criteria for including several models (marks) of a medical device in one registration certificate, as set forth in Paragraph 19 of the EEC Decision No. 46;

Changes that result in a simultaneous change of information about the manufacturer and the production site, except for information on the organizational and legal form, address, reorganization, or other information contained in the constituent documents.

The Amendments procedure may be carried out:

• With an expertise of the quality, effectiveness, and safety of the medical device;
• In a notification-based procedure.

The regulatory body of the reference state (the state where the state registration of the medical device was performed) carries out the amendments. In the Russian Federation, this body is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). If the Amendments procedure involves an expertise, approval of the expert report in the concerned state is also required.

State Fee for Amending the Registration Dossier under the EAEU Procedure

The law of the reference state determines the amount of the state fee for such actions. In the Russian Federation, Article 333.32.2 of the Tax Code of the Russian Federation establishes the following fees:

• For making amendments to the documents contained in the registration dossier of a medical device that do not require an expertise of the quality, effectiveness, and safety of the medical device — 2,500 rubles
• For conducting an expertise of quality, effectiveness, and safety when making amendments to the documents contained in the registration dossier of a medical device, depending on the potential risk class of the medical device:

1) Class 1 — 32,000 rubles;

2) Class 2a — 48,000 rubles;

3) Class 2b — 64,000 rubles;

4) Class 3 — 104,000 rubles.

For approval of an expert report on the assessment of safety, effectiveness, and quality of a medical device when making amendments to the documents, depending on the potential risk class of the medical device:

1) Class 1 — 32,000 rubles;

2) Class 2a — 48,000 rubles;

3) Class 2b — 64,000 rubles;

4) Class 3 — 104,000 rubles.

Let us examine the notification-based and expertise-based Amendments procedures in more detail.

Amending the Registration Dossier in a Notification-Based Procedure

According to Paragraph 87 of the EEC Decision No. 46, amending the registration dossier in a notification-based procedure is carried out in the following cases:

• Changes in the validity periods of documents contained in the registration dossier (updating of registration dossier documents by the applicant);
• Changes in information on the assessment of the quality management system of the medical device (regarding medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a);

Changes in the following information about the medical device manufacturer or its authorized representative:

a) the name of the legal entity, the location address, or the address of the place of business;

b) the full name, the place of residence of an individual entrepreneur, or the address of the place of business and the details of the identity document;

• Changes in the name of the medical device regarding the trademark and other means of individualization;
• Exclusion of information on a model (mark) of a medical device from the registration certificate.

To make amendments, the applicant shall send the following set of documents to the regulatory body of the reference state:

An application for amendments on paper and (or) in electronic form according to the form provided in Appendix No. 9 to the EEC Decision No. 46;

A copy of the document confirming the powers of the manufacturer's authorized representative;

Documents and information on the relevant changes, including documents proving that making these changes:

a) does not result in changes to the properties and characteristics of the medical device affecting its safety, quality, and effectiveness;

b) improves its properties and characteristics while maintaining the functional purpose and (or) principle of operation of the medical device;

A report on the results of the production inspection (for medical devices of Class 1 and non-sterile Class 2a that have undergone production inspection);

• Copies of documents confirming payment for the Amendments procedure;
• The original registration certificate (if it is necessary to make changes to it);
• An inventory of documents.

Stages of the Amendments Procedure in a Notification-Based Procedure

1. Verification of the completeness and accuracy of the contained information.

After receiving the application and documents, the regulatory body conducts a check of the completeness and accuracy of the submitted information within 7 business days.

If the documents are not submitted in full, the regulatory body notifies the applicant of the need to eliminate the identified violations by posting a corresponding notification in its information system or by another method confirming receipt by the applicant. The deadline for eliminating deficiencies is 30 business days. If the violations are not eliminated within the specified period, the application is returned with an indication of the reasons for the return.

2. Adoption of a decision to start the procedure for making amendments to the documents.

If the documents and information are submitted in full or if the deficiencies are eliminated in a timely manner, the regulatory body shall, within 3 business days, adopt a decision to start the procedure for making amendments and post the registration dossier containing the application for amendments in its information system.

3. Adoption of a decision to make amendments to the registration dossier.

Within 15 business days from the date of adopting the decision to start the procedure for making amendments, the regulatory body shall make the amendments to the registration dossier. The notification-based Amendments procedure does not require coordination with the concerned states.

According to Paragraph 98 of the EEC Decision No. 46, the grounds for refusal to make amendments are:

Inaccuracy of the submitted information justifying the notification-based amendments (including the expiration of the report on the results of the production inspection);

• Inconsistency of the submitted documents and information;
• The need for a new registration of the medical device;
• Inconsistency of the amendments being made with the cases where the Amendments procedure is carried out in a notification-based manner.

In the event of a positive decision, the regulatory body shall, within 5 business days, perform the following activities:

• Post information on the amendments to the registration dossier in the Unified Register of Medical Devices Registered within the EAEU (the "Unified Register of EAEU Medical Devices");
• Prepare and issue to the applicant a notification of the amendments, as well as, if necessary, the reissued registration certificate and the appendix thereto.

Amendments Procedure Requiring an Expertise of the Quality, Effectiveness, and Safety of the Medical Device

In other cases, an expertise of quality, effectiveness, and safety is required to make amendments.

To start such a procedure, the applicant shall submit the following documents to the regulatory body of the reference state:

• An application containing information on the amendments being made according to the form provided in Appendix No. 7 to the EEC Decision No. 46;
• Copies of documents confirming the powers of the manufacturer's authorized representative (if an authorized representative is present);
• Information on the results of clinical trials of the medical device (if applicable to the given medical device);
• Documents that have undergone the relevant changes and prove that the amendments: (1) do not result in changes to the properties and characteristics of the medical device affecting its safety, quality, and effectiveness; (2) improve its properties and characteristics while maintaining the functional purpose and (or) principle of operation of the medical device;
• Copies of documents confirming payment for the Amendments procedure and the procedure for coordination of the expert report in the concerned state, as well as for the issuance of the registration certificate in the reference state (if necessary);
• The original registration certificate;
• An inventory of documents.

Stages of the Amendments Procedure Requiring an Expertise of the Quality, Effectiveness, and Safety of the Medical Device

1. Verification of the completeness and accuracy of the information.

Within 7 business days from the date of receipt of the application and documents, the regulatory body conducts a check of the completeness and accuracy of the information contained therein. The procedure for verification and elimination of violations is similar to the notification-based Amendments procedure. If the violations are not eliminated within 30 business days, the application is returned to the applicant.

2. Adoption of a decision to start the procedure for making amendments to the documents.

If the documents and information are submitted in full or if the violations are eliminated, the regulatory body shall, within 3 business days, adopt a decision to start the Amendments procedure and post the application and documents in its information system.

3. Conducting an expertise of the quality, effectiveness, and safety of the medical device.

The authorized expert organization of the reference state conducts the expertise within a period not exceeding 30 business days from the date of adopting the decision to start the Amendments procedure, and the results are documented in an expert report.

If the information for conducting the expertise is insufficient, the regulatory body sends a corresponding request to the applicant, indicating the comments and methods for their elimination. The response to the request must be provided within 60 business days from the date of its receipt. If no response is submitted, a decision is made based on the documents available.

Based on the results of the expertise, the expert institution sends a report to the regulatory body regarding the possibility of making amendments to the registration dossier documents or the impossibility of such amendments.

The grounds for preparing a report on the impossibility of making amendments to the registration dossier are:

• Inaccuracy of the submitted information justifying the amendments;
• Absence in the submitted documents of information confirming that the changes do not result in changes to the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or that they improve the properties and characteristics while maintaining the functional purpose and (or) principle of operation of the medical device;
• The need for a new registration of the medical device in accordance with Paragraph 67 of the EEC Decision No. 46.

4. Evaluation of the report of the expert institution.

Within 10 business days from the date of receiving the expert report, the regulatory body evaluates it. In the case of a negative report, a decision to refuse the Amendments procedure is adopted, and the applicant is notified of the reasons with a copy of the expert report attached. In the case of a positive report, the regulatory body posts it in its information system.

5. Coordination of the expert report in the concerned states.

In the case of a positive expert report, its coordination in the concerned states is also required. Coordination occurs according to a procedure similar to coordination during the registration of a medical device.

The applicant must pay for and submit copies of documents confirming payment for the coordination procedure within 30 calendar days from the date the regulatory body sends the notification. In addition, it will be necessary to submit translations of the required documents into the state language of the concerned state to the regulatory body of that state.

When conducting the coordination procedure, the regulatory body of the concerned state evaluates the completeness and sufficiency of the data confirming the safety, quality, and effectiveness of the medical device, as well as the correctness of the translation of the documents. 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 on the Confirmation of Coordination (Non-coordination) of the Expert Report is prepared.

6. Adoption of a decision to make amendments to the registration dossier or to refuse.

After receiving confirmation of the coordination of the expert report in the concerned states, the regulatory body shall, within 10 business days, adopt a decision to make amendments to the registration dossier and enter the relevant changes into the Unified Register of Medical Devices.

If a concerned state has not coordinated the expert report, the regulatory body adopts one of the following decisions:

• To refuse the Amendments procedure if it agrees with the conclusions of the regulatory body of the concerned state;
• To make the amendments and exclude the concerned state from the registration certificate if there are objections to the decision of the concerned state.

The applicant is notified of the adopted decision. When making the amendments, the applicant is also issued a reissued registration certificate and an appendix thereto, maintaining the former number, and the previously issued registration certificate is returned with a mark of its invalidity.

Challenging a Refusal of the Amendments Procedure under EAEU Rules

In accordance with Paragraph 10 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices, the manufacturer of a medical device or its authorized representative may appeal a regulatory body's decision to refuse to issue a registration certificate in court in the manner provided for by the legislation of that member state. In our view, a regulatory body's decision to refuse the Amendments procedure, or to suspend or annul a registration certificate, may be appealed in the same manner.

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

• Inconsistency of the challenged decision or action (inaction) with the law or another legal act;
• Violation of the rights and legitimate interests of the applicant in the field of entrepreneurial and other economic activities, or the unlawful imposition of any duties on the applicant, or the creation of other obstacles to the performance of entrepreneurial and other economic activities.

Given that not many medical device manufacturers have yet performed registration under EAEU law, there is currently no judicial practice regarding issues related to Amendments, or the suspension and cancellation of registration under EAEU norms.

Summing up, we note that there are significantly fewer grounds for making amendments to the registration dossier, or for the suspension and cancellation of registration under EAEU rules compared to the procedure established by Russian legislation. Furthermore, the Amendments procedure under EAEU law is more complex due to the presence of additional procedures for coordinating the expert report by the concerned state.

At the same time, to avoid negative consequences in the form of the suspension and cancellation of the registration certificate, manufacturers and their authorized representatives must carry out regular quality control of the manufactured devices and initiate the procedure for amending the registration dossier in a timely manner.