Author name: Operon Strategist

medical device manufacturing

How to Set Up a Medical Device Manufacturing Plant in Egypt: Layout Design, Cleanroom, and Validation Guide

Medical device Manufacturing /

The Growing Opportunity for Medical Device Manufacturing in Egypt The medical device manufacturing industry in Egypt is expanding rapidly, fueled by rising healthcare needs, supportive government policies, and increasing foreign investment. For companies planning to establish a compliant facility, focusing on plant layout design, cleanroom construction, and process validation is essential. These elements not only […]

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IVD manufacturing

How to Set Up an IVD Manufacturing Plant: Key Steps and Best Practices

Medical device Manufacturing /

Why Egypt is Emerging as a Hub for IVD Manufacturing? The In Vitro Diagnostic (IVD) manufacturing industry in Egypt is witnessing significant growth, driven by rising healthcare needs, increasing demand for accurate diagnostic solutions, and strong government initiatives supporting local production. As Egypt positions itself as a regional leader in healthcare innovation, IVD manufacturing has

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EDA Authorized Representative

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

Regulatory 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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