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The circulation of medical devices within the Eurasian Economic Union is regulated by the Treaty on the Eurasian Economic Union of May 29, 2014, the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, other international treaties enacted as laws of the Union, decisions of the Commission, and laws of the member states. Within the Eurasian Economic Union, medical devices are registered in accordance with the Rules for Registration and Examination of Safety, Quality and Efficacy of Medical Devices approved by Resolution No. 46 dated February 12, 2016 of the Council of the Eurasian Economic Commission.

A medical device may be registered in one or several member states. Registration of a medical device is confirmed by a Registration Certificate that is issued for an indefinite period of time. Moreover, a registered medical device obtains special labeling for medical devices that circulate within the Eurasian Economic Union. A registration application may be submitted by a manufacturer resident in a member state or their authorized representative, who must be also a resident of the member state. For registration in several member states, a single authorized representative is appointed for all of them.


Amendment of registration documents under the EAEU rules and national regulations

In pursuance of the amendments to the Agreement on Common Principles and Rules for Circulation of Medical Devices (Medical Products and Medical Equipment) Within the Eurasian Economic Union dated December 23, 2014, amendments can be made to the registration dossier of a medical device in accordance with national regulations until December 31, 2026.


Preparation of technical and operational documentation

Medalis provides assistance in the preparation/refinement of technical documentation and operational documentation for the registration of a medical device. High-quality technical and operational documentation prepared in compliance with applicable regulations is the most important source of information about a medical device. The service is essential for manufacturing companies that obtain registration for their medical devices independently but lack experience in preparing certain documents. Unfortunately, errors in documents submitted to the registering authority (the Federal Service for Surveillance of Healthcare) result in a large number of refusals and cost a huge amount of money and time. Therefore, our job is to prepare a document of the highest standards, compliant with all applicable regulatory requirements.


Arrangement of medical device testing

Medalis arranges the performance of all necessary tests: technical, toxicological, clinical and EMC testing. Our team monitors the entire process of testing and also inspects all test results for compliance with regulatory requirements. We collaborate only with true and trusted laboratories with well-established reputations.


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