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Why Medical Device Classification Matters in Egypt? When entering Egypt’s healthcare market, regulatory compliance is a critical step for medical device manufacturers. The Egyptian Drug Authority (EDA) oversees the classification, registration, and approval of medical devices, with strict protocols to ensure patient safety and device effectiveness. At Operon Strategist, we’ve supported numerous manufacturers through every […]

Why IV Set Manufacturing Matters in Egypt The demand for medical disposables, especially intravenous (IV) sets, has grown rapidly across emerging healthcare markets. Egypt, with its expanding hospital infrastructure and strategic geographic position, offers a valuable opportunity for companies involved in IV set manufacturing. With increasing public and private investment in healthcare services, the need

For foreign medical device manufacturers looking to enter the Egyptian market, appointing an Authorized Representative (AR) is a critical regulatory requirement. The Egyptian Drug Authority (EDA) mandates that companies without a physical presence in Egypt must appoint an AR to manage compliance, registration, and post-market activities. Choosing the right AR ensures a smooth market entry