Regulatory Authority

Egyptian Drug Authority (EDA)


I, IIa, IIb, III, IV

Quality system

ISO 13485:2016

All Medical Devices must be registered with CAPA (Central Administration of Pharmaceutical Affairs) and obtain the Marketing Authorization.
Manufacturers with no local presence in Egypt must appoint an Egyptian Registration Holder.


Egypt Registration Holder (ERH)

Timeframe and fees

At least 5 months.


10 years

Labelling and documentation language

Home use labelling must be provided in Arabic and professional use labelling must be provided in English.


    Do you want to market your Medical Device in this Country? Contact us!

    Newsletter Subscription