AIFA
Agenzia Italiana del Farmaco
About
AIFA works alongside the Italian Ministry of Health for medical device regulation in Italy. The Italian Ministry of Health's Directorate General for Medical Devices handles device-specific regulation under EU MDR.
Regulatory Details
Regulatory FrameworkEU MDR 2017/745 (Italian implementation)
Device ClassificationClass I, Class IIa, Class IIb, Class III
Jurisdiction TypeNational
Country🇮🇹 Italy
StatusActive