MEDICAL DEVICE REGULATION IN EGYPT

 

Medical Device is regulated by the Central Administration for Pharmaceutical Affairs (CAPA) from the Egyptian Drug Authority (EDA) whose objective is to ensuring that the community has access to safe, effective affordable & secure products.

 

MEDICAL DEVICE REGISTRATION AND APPROVAL IN EGYPT

 

Medical devices are classified into 4 categories namely class I, IIa, IIb and III (I being the lowest risk and III being the highest risk) and is based on CE classification.

 

CE Marking for the Medical Device is highly recommended to get a registration approval from CAPA.