: 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.
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