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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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