Tag Archives: eac

Roszdravnadzor seminar

Posted on by

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) holds a workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union”. A workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union” was held in Moscow

Read more

EAC MED

Posted on by

“Approved once, accepted everywhere” – main idea for EEU medical regulatory affairs. Expected regulation for all medical devices has a lot of unknowns: 1. Harmonization – base of acceptance criteria- is still in process. 2. Classification rules for medical devices – different for each country for this moment and only Russia has clear nomenclature (4n classification rules). 3. Acceptance process

Read more