
Medical device approvals in the EAEU
The Eurasian Economic Union (EEU or EAEU) is an international organization for regional economic integration.
January 1, 2015 the Agreement on the Eurasian Economic Union EEU has become effective. The Agreement confirms the creation of an economic union that provides for free movement of goods, services, capital and labor and pursues coordinated, harmonized and single policy in the sectors determined by the document and international agreements within the Union.
The Agreement on the EEU was signed by the Presidents of the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation on May 29, 2014, in Astana. Apart from the three states, the Union members will also include the Republic of Armenia that signed Agreement on Accession to the Union on October 10, 2014 and the Kyrgyz Republic that signed similar Agreement on December 23, 2014.
The Eurasian Economic Commission (EEC) is the permanent supranational regulatory body of the Union, formed by the Commission's Council and the College of the Commission. The Council includes the Deputy Prime Ministers of the member states. The composition of the EEC College is made up of the Chairman and the Ministers of the Commission.
The main tasks of the Commission are to ensure the functioning and development of the EAEU and to develop proposals in the field of economic integration within the EAEU. The EAEU creates conditions for the stable development of the economies of the member states, their comprehensive modernization, and increasing their competitiveness on a global scale. In its establishment, both the own experience of integration interaction of the member states, primarily within the CIS, EurAsEC, Customs Union, and the Single Economic Space, as well as advanced international developments, including the practice of the World Trade Organization (WTO), were taken into account.
One of the key development directions is cooperation in healthcare, specifically in creating a single market for the circulation of medical devices and pharmaceutical products.
The path of medical device registration within the EAEU is quite ambiguous. Based on the EAEU Treaty of 29.05.2014, an Agreement "On the uniform principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union" was issued, which came into force on 12.02.2016. Simultaneously, on 12.02.2016, the Decision No. 46 of the EEC Council "On the rules of registration and examination of safety, quality, and efficacy of medical devices" came into force, which set the requirements for the registration dossier and established a transition period until 31.12.2021. During this period, there was an opportunity for registration both within the EAEU and within the national registration systems of the member states. From 01.01.2022, the transition period and national registration rules expired. From 01.01.2022 to 01.04.2022, only the EAEU registration rules for medical devices were in effect in Russia. Starting from 01.04.2022, the Government Resolution No. 552, which regulates registration within the national system until 01.01.2025, has been in effect.
The market faced again a choice between registration under the EAEU and under national rules. Also, the registration rules are being improved annually and adapted to the modern trends of the member states. As of now (May 2024), 42 medical devices have been registered throughout the existence of the EAEU. The advantage of this procedure is that the registration certificate immediately applies in the selected recognition countries, which allows for reducing the registration period without resorting to the national rules of the recognition countries.