Introduction to registration of medical devices according to the requirements of the EAEU
From January 01, 2022, registration of a medical device (MD) under the national procedure will not be possible. This will affect the countries of the Eurasian Economic Union — Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan. The national process specific to each country will be replaced by a single harmonized procedure.
It should be noted that legally, applicants had the right to use the procedure for registering MD in the EAEU since 2016, but in fact this was impossible due to the immaturity of the EAEU regulatory framework. As a result, information about the first medical device registered under the new rules appeared in December 2019. The MD is a phototherapy neonatal irradiator of Russian production. Its circulation is possible on the territory of Russia and Kyrgyzstan, where Russia is the reference state*, and Kyrgyzstan is the state of recognition**.
According to the unified register of medical devices registered within the EAEU, since December 2019, registration certificates (RC) have been issued for other 6 MD (1 in Kazakhstan as a reference country, 2 in Belarus and the rest in Russia), manufactured in Russia, Belarus and the USA. At the same time, Roszdravnadzor issued the first RC for MD within the EAEU with a primary inspection of manufacturing sites in 2020. The product is a “Kit of reagents for the quantitative determination of a total prostate-specific antigen by means of enzyme immunoassay” of Russian production. As part of the inspection for compliance with the requirements for the implementation, maintenance and evaluation of the quality management system of MD, depending on the potential risk of their use, the expert center of Roszdravnadzor – Federal State Budgetary Institution “VNIIMT” inspected two production sites in Nizhny Novgorod.
As can be seen from the above, that successful experience of MD registration according to the requirements of the EAEU is not vast for both the applicants and health authorities. This is especially true for foreign-made MD that require inspection of production (MD of 2b, 3 risk classes, sterile medical devices of risk class 2a).
The good news is that according to Order No. 142 dated September 2, 2019 RCs, issued before December 31, 2021, will be valid until their expiration, i.e. :
- For the Russian Federation: unlimited period;
- For rep. Kazakhstan: unlimited period;
- For rep. Belarus: 5 years;
- For rep. Kyrgyzstan: unlimited period.
- For rep.Armenia there is no national registration procedure.
Read more about the harmonized registration procedure within the EAEU, as well as national procedures for MD registration in the EAEU member states, in the new articles of the section.
Consultation on registration of a particular MD under the rules of the EAEU – firstname.lastname@example.org
- Decision of the Council of the Eurasian Economic Commission of February 12, 2016 N 46 “On the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Devices”
- Decision of the Council of the Eurasian Economic Commission of November 10, 2017 N 106 “On the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System of Medical Devices, Depending on the Potential risk of their use”
- Order No. 142 of the EEC Board dated September 2, 2019 “On the Draft Protocol on Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Devices and medical equipment) within the framework of the Eurasian Economic Union dated December 23, 2014”