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: January 2024

Medical Device Regulations and Classification in Egypt

REGULATORY AUTHORITY: Central Administration of Pharmaceutical Affairs (CAPA)

CLASSIFICATION SYSTEM: The Egyptian authorities implemented 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.

LICENSE TRANSFER:

License transfer is not possible.

AUTHORIZED REPRESENTATIVE:

The manufacturer should sign an agreement with a local License Holder who will also be the official importer.

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

 

JUST SAY WHEN!

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 country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?