Tag Archives: EAC

Roszdravnadzor seminar

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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

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EAC MED

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“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

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