REGULATORY AUTHORITY:
Egyptian Drug Authority (EDA)
CLASSIFICATION SYSTEM:
Medical Devices: 1, 2a, 2b, 3.
IVDs: List A, List B, and General/Other or Self-Testing.
TIMEFRAME:
6-12 months for a regular registration pathway.
3-4 months for a fast-track registration pathway.
SPECIAL REQUIREMENTS:
Not applicable.
LOCAL FEES (New Application):
Regular track – USD 450/device
Fast track – USD 1280/device
LOCAL FEES (Manufacturer):
Not applicable
LICENSE VALIDITY:
10 years.
LICENSE TRANSFER:
License transfer is not possible.
AUTHORIZED REPRESENTATIVE:
Manufacturers with no local presence in Egypt must appoint an Egyptian Registration Holder (ERH).
ADDITIONAL INFORMATION:
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.
Other Middle East & North Africa Countries: Algeria,Bahrain, Israel,Jordan,Kuwait,Lebanon,Morocco,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates ,Yemen
Last Update September 2022
