REGULATORY AUTHORITY: Egyptian Drug Authority (EDA)

CLASSIFICATION SYSTEM: The Egyptian authorities have adopted the EU classification system, which is I, IIa, IIb, III for medical devices and A, B, C, D for IVD.

TIMEFRAME: The registration process takes 6-8 months

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 for medical devices

5 years for IVDs

LICENSE TRANSFER:

License transfer is not possible.

AUTHORIZED REPRESENTATIVE:

The manufacturer should sign an agreement with an Egyptian Registration Holder (ERH) or a scientific office to register medical devices. In the case of ERH, it can also be the importer unless the manufacturer has appointed another party. However, this is not the case for Scientific offices. However, it is permissible for the scientific office to authorize a third-party importer to handle the importation process.

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