Egyptian Drug Authority (EDA)
Medical Devices: 1, 2a, 2b, 3.
IVDs: List A, List B, and General/Other or Self-Testing.
6-12 months for a regular registration pathway.
3-4 months for a fast-track registration pathway.
LOCAL FEES (New Application):
Regular track – USD 450/device
Fast track – USD 1280/device
LOCAL FEES (Manufacturer):
License transfer is not possible.
Manufacturers with no local presence in Egypt must appoint an Egyptian Registration Holder (ERH).
Registration is now required for all devices, including class 1 (non-sterile) but the license holder (LH) can list the device into the importation record without waiting for the registration certificate issuance.