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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Egypt, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Egypt

REGULATORY AUTHORITY: Medical devices are regulated by the Central Administration for Pharmaceutical Affairs (CAPA), part of the Egyptian Drug Authority (EDA).

CLASSIFICATION SYSTEM: Egypt has adopted the European Risk Classification System for medical devices (Class I, IIa, IIb, III and IV).

TIMEFRAME: The timeframe for the registration process is six months.

LICENSE VALIDITY: Licenses issued in Egypt are valid for ten years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on March 17 2015.