MEDICAL DEVICE REGISTRATION AND APPROVAL IN Egypt

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
Last update: December 2022

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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