CMIKEE seminar 17.04.2018 about EAC MED

Main information from yesterday seminar provided by FGBU CMIKEE (full Russian name is ФГБУ «Центр мониторинга и клинико-экономической экспертизы» Росздравнадзора) with main theme “Medical device registration: features in regulation for Russia and EAEU” (including clinical trials, factory audit, technical file preparation):

1 – nobody knows when EAC MED mark will start by fact (a lot of regulatory documents are still under preparation);

2 – Russian Federation is going to initiate question about current national registration certificate prolongation and become in action in EAEU regulation only for Russia without expiry date. It could be, of course, blocked by another members – looks like violation of union rules of single market;

3 – nobody knows how expected regulation will work by fact – expert centers has no experience in documents review.

4 – it is impossible to do registration certificate without listing of REC countries – you must have at least one recognition country during submission process.