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Roszdravnadzor seminar

Posted on Thursday September 29th, 2016 by beawire

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

Roszdravnadzor

EAC MED

Posted on Friday August 19th, 2016 by beawire

“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