Suspension and Cancellation of Medical Device Marketing Authorizations under EAEU Rules

 

April 22, 2026

BRACE Law Firm ©

 

The procedure for the suspension and cancellation of marketing authorizations (the "MA") under the law of the Eurasian Economic Union (the "EAEU") is regulated by the Rules of Registration and Examination of 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").

Suspension of Marketing Authorizations for Medical Devices under the EAEU Rules

The competent authority suspends the registration of a medical device if violations are identified during its circulation.

According to Clause 114 of the EEC Decision No. 46, the competent authority shall suspend a marketing authorization in the following cases:

1. Based on the results of monitoring the safety, quality, and effectiveness of medical devices during the post-registration period upon identifying a potential serious threat to human health.

Monitoring safety includes the collection, registration, and analysis of information regarding adverse events (incidents) and the adoption of corresponding decisions. It is based on:

• the analysis of reports on adverse events (incidents) received from users and manufacturers of medical devices, as well as authorities of the EAEU member states authorized to exercise state control over the circulation of medical devices;
• the analysis of periodic safety and clinical effectiveness reports for class 3 medical devices and implantable medical devices of classes 2b and 3, received from manufacturers of medical devices or their authorized representatives;
• the system for collecting and analyzing manufacturer data regarding the safety and effectiveness of medical devices at the post-market stage.

The procedure for conducting monitoring in relation to medical devices registered under EAEU law is regulated by Decision of the Collegium of the Eurasian Economic Commission No. 174 dated December 22, 2015.[1]

2. Based on the results of state control (supervision) over the circulation of medical devices in the presence of information on facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of medical devices.

In the Russian Federation, Roszdravnadzor is responsible for state control over the circulation of medical devices. The procedure for its implementation is regulated by Government Decree No. 1066 dated June 30, 2021.[2]

The subject of control includes:

• compliance with requirements for the circulation of medical devices;
• compliance with licensing requirements for the production and maintenance of medical equipment;
• compliance with requirements for providing information on the identification of adverse events during the circulation of medical devices;
• execution of decisions adopted based on the results of control measures.

Further details on the procedure for its implementation can be found in our specialized article on this topic.[3]

3. The absence of current information in the registration dossier regarding the authorized representative of the manufacturer (for manufacturers from countries that are not members of the EAEU).

The competent authority of the reference state makes the decision to suspend in accordance with the legislation of that state, specifying the reasons, date, and term of suspension. The suspension period shall not exceed 6 months. During this period, the sale and use of such medical devices are prohibited in the reference state and the concerned state.

Within 5 business days, the competent authority enters the relevant information into the Single Registry of Medical Devices of the EAEU and informs the competent authorities of the concerned states, the Eurasian Economic Commission, and the applicant. This notification includes the reasons, date, and term of the suspension, as well as the necessity for the applicant to eliminate the circumstances that led to the suspension of the marketing authorization.

The applicant must eliminate the circumstances that led to the suspension within the period established by the competent authority and provide written notification thereof, along with supporting documents.

Based on the results of reviewing the documents submitted by the applicant, the competent authority decides to either resume or cancel the marketing authorization. The decision to resume the validity of the marketing authorization takes effect from the date of its adoption.

If the applicant fails to eliminate the circumstances that led to the suspension within the established period, the competent authority of the reference state shall, within 3 business days from the expiry of the specified period, adopt a reasoned decision to cancel the marketing authorization.

As of the date of this article, the Single Registry of Medical Devices contains information on three marketing authorizations belonging to manufacturers from foreign states that are not members of the EAEU, the validity of which has been suspended.

Cancellation of a Marketing Authorization or Cancellation of Medical Device Registration

In accordance with Clause 123 of the EEC Decision No. 46, the grounds for adopting a decision to cancel a marketing authorization or to cancel the registration of a medical device (models or brands of the medical device specified in the marketing authorization) are:

• the manufacturer’s application;

The manufacturer submits the application in hard copy or electronic form according to the form provided in Annex No. 13 to the EEC Decision No. 46. The authorized representative of the manufacturer may also submit the application if the following conditions are met collectively:

• the registration dossier contains a current document confirming the representative’s authority, or such a document is submitted along with the application;
• the submission of a document from the manufacturer confirming its intention to cancel the marketing authorization.

If the application is submitted in violation of the requirements, the competent authority shall decide to return it within 7 business days from the date of receipt.

the identification of cases where the applicant submitted false information that could not be established during the registration of the medical device (including during the exercise of state control over the circulation of medical devices by competent authorities);

• a legally effective court decision of an EAEU member state to cancel the marketing authorization;
• the submission of information by the competent authority, based on the results of state control over the circulation of medical devices, regarding facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of the medical device;
• the medical device loses its medical status due to amendments to EAEU law or based on a decision by the Advisory Committee following the resolution of disagreements regarding the classification of products as medical devices.

As a reminder, the criteria for classifying products as medical within the EAEU were approved by Decision of the Collegium of the EEC No. 25 dated November 12, 2018. One of the main criteria is the intended purpose of the medical device. Such medical purpose must be the sole or primary purpose.

Within 7 business days from the occurrence of one of the specified grounds, the competent authority of the reference state shall adopt a decision to cancel the marketing authorization.

After adopting such a decision, the competent authority shall, within 5 business days

• post the relevant information in the Single Registry of Medical Devices of the EAEU
• notify the applicant of the cancellation of the marketing authorization;
• notify the applicant of the cancellation of the medical device registration (models or brands of the medical device specified in the marketing authorization) and the need to amend the registration dossier to exclude these medical devices.

Furthermore, pursuant to Article 8 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union,[4] the competent authority shall immediately inform the competent authorities of other EAEU member states and the Eurasian Economic Commission regarding the cancellation of a marketing authorization for a medical device.

As of the date of this article, the Single Registry of Medical Devices of the EAEU contains information on 3 marketing authorizations that have been cancelled. However, this insignificant number is due to the small number of medical device registrations under EAEU law compared to national legislation, rather than insufficient control by competent authorities.

Challenging the Suspension and Cancellation of Marketing Authorizations under the EAEU Rules

In accordance with Clause 10 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union, a manufacturer or its authorized representative may appeal a competent authority's decision to refuse the issuance of a marketing authorization in court, following the procedure provided for by the legislation of that member state. In our view, a decision of the competent authority to suspend or cancel a marketing authorization may be appealed in the same manner.

In the Russian Federation, such an appeal is conducted according to the rules of Chapter 24 of the APC RF, Challenging Non-Normative Legal Acts, Decisions, and Actions (Inaction) of State Authorities. For a court to grant the application, the applicant must collectively prove the following circumstances:

• the challenged decision or action (inaction) does not comply with the law or another legal act;
• the challenged decision or action violates the rights and legitimate interests of the applicant in the field of entrepreneurial and other economic activity, or illegally imposes any obligations on the applicant, or creates other obstacles to the implementation of entrepreneurial and other economic activity.

Given that only a few medical device manufacturers have completed registration under EAEU law, there is currently no judicial practice regarding issues related to the suspension and cancellation of registration under EAEU norms.

___________________________

References

[1] Decision of the Collegium of the Eurasian Economic Commission No. 174 dated December 22, 2015, On Approval of the Rules for Monitoring the Safety, Quality, and Effectiveness of Medical Devices.

[2] Government Decree No. 1066 dated June 30, 2021, On Federal State Control (Supervision) over the Circulation of Medical Devices.

[3] See: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/gosudarstvennyj-kontrol-za-obrashcheniem-meditsinskikh-izdelij-i-monitoring-ikh-bezopasnosti.

[4] Concluded in Moscow on December 23, 2014.