Medical Device Registration and Approval in Egypt

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

Medical Device Regulations and Classification in Egypt

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,BahrainIsrael,Jordan,Kuwait,Lebanon,Morocco,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates ,Yemen

Last Update September 2022

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For detailed device-specific compliance information for each market, including Egypt, to expedite the preparation of your medical device or IVD registration application.

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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.

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