Regulatory Compliance

Introduction Egypt has rapidly emerged as a strategic hub for medical technology in the Middle East and Africa. With rising cardiovascular disease prevalence, expanding healthcare infrastructure, and strong government support for local manufacturing, the demand for cardiology devices in Egypt is growing steadily. For international manufacturers planning to import cardiology devices or establish manufacturing facilities […]

Entering the Egyptian medical device market requires securing EDA approval, a mandatory regulatory step governed by the Egyptian Drug Authority (EDA). A crucial part of this process involves the preparation of comprehensive and compliant technical documentation that aligns with EDA requirements. Accurate and complete documentation is essential for achieving EDA approval, facilitating market entry, and

Medical Devices – Roles, Compliance & EDA Requirements For foreign medical device manufacturers aiming to access the Egyptian market, appointing an Authorized Representative (AR) in Egypt is not optional—it is a mandatory requirement by the Egyptian Drug Authority (EDA). An AR ensures that your medical devices comply with EDA regulations, supports registration, and manages post-market