Regulatory Authority
Egyptian Drug Authority (EDA)
Classification
I, IIa, IIb, III, IV
Quality system
ISO 13485:2016
The information on this page is valid and current as of January 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
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.
Applicant
Egypt Registration Holder (ERH)
Timeframe and fees
At least 5 months.
Validity
10 years
Labelling and documentation language
Home use labelling must be provided in Arabic and professional use labelling must be provided in English.
