The Eurasian Economic Union (EAEU) is an international economic integration organisation with 183.6 million inhabitants that includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russian Federation.
EAEU has recently started process of harmonisation of marketing authorisation requirements for medical products, including medical devices.
Thus, marketing authorisation performed according to EAEU Technical regulations give access to the market of every EAEU member state.
Transition period for medical devices is in force enabling market authorisation by both “national” and “centralised” procedures.
However all medical devices registered by “national” procedures must be brought in compliance with EEU Technical regulations until December 31, 2021.
At the first glance new conformity assessment procedure described in EAEU Technical regulations has some similarity with EU Medical Device regulations but has significant differences in details.
National conformity assessment bodies of EAEU member states will recognise technical studies and tests, toxicological and preclinical data in case of it's compliance with the requirements and rules established by the Commission of EAEU.
It is required to designate Authorised representative that should be resident of EAEU, to draw national Declaration of conformity, to affix national symbol of conformity as well as to perform other specific national requirements.