Medical Device Classification

The Ultimate Guide to Medical Device Classification Under EDA Regulations

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 […]

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IV Set Manufacturing

IV Set Manufacturing in Egypt: A Strategic Guide for Medical Device Enterprises

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

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EDA Authorized Representative

EDA Authorized Representative for Medical Devices in Egypt: Roles and Compliance

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

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