General country-specific regulatory information is provided on this page for medical device registration and approval in Egypt.
We review our Regulatory Information frequently; please check back often for updates
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.
For detailed device-specific compliance information for each market, including Egypt, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
