Russia has been a member of the Eurasian Economic Union (EAEU) since January 1, 2015. The main benefit for medical device manufacturers from belonging to the EAEU is a one-time registration (in any of the EAEU member states) after which they can sell their products in any countries that have recognized the EAEU rules, namely: Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic and Russian Federation.
In the EAEU, medical devices are now registered according the Rules for Registration and Expert Examination of Medical Devices for Safety, Quality and Efficacy, approved by the Decision No. 46 of the EAEU Council, dated February 12, 2016.
Registration of medical devices is mandatory, since the supervisory authorities of the Member States are responsible for monitoring the quality and safety of medical products sold in the EAEU market. Only registered products are allowed to circulate in the EAEU.
Things you should know:
A medical device can be registered in one or in several EAEU member states.
A registered medical device is marked with a special medical device circulation mark.
The registration of a medical device under the EAEU regulation differs from registration according to the national standard in that it involves one-step registration irrespective of the hazard class.
The medical device registration document will have an indefinite validity period.
In case the documentary evidence is not sufficient, a permit for clinical trials is issued. This is necessary to confirm the functional safety of the medical device. Clinical studies and, accordingly, clinical trials involving patients are required in that case.