Strategic Regulatory Partner for Success in Egypt

Since September 2018, medical device registration has become mandatory in Egypt. The medical device industry in the country has witnessed consistent growth, rendering an appealing market for manufacturers and distributors. With a valuation of $4.0 billion in 2021, the Egyptian medical devices market is projected to achieve a Compound Annual Growth Rate (CAGR) of over 3% from 2022 to 2027. Importation largely fulfills the demand for medical devices in Egypt, given the relatively low local production. Remarkably, the Egyptian medical devices market stands as the second largest in the Middle East and North Africa (MENA) region. This overview explores key aspects of the Egyptian registration process, offering insights into the Regulatory framework and requirements for bringing innovative medical devices to the forefront of Egypt’s healthcare sector.