EDA Registration - Expert Services for Egyptian Drug Authority

The Egyptian Drug Authority (EDA), established in 2019, is responsible for regulating medical devices and pharmaceuticals in Egypt. To register a medical device, applicants must be legally registered entities in Egypt, and if the manufacturer is outside the country, a local representative is required. The registration process involves completing an official application form, providing detailed product information, and demonstrating compliance with quality management system standards, such as ISO 13485. Additionally, evidence of any existing regulatory approvals (e.g., CE marking or FDA clearance) and, depending on the device, clinical evaluation data may be necessary. Applicants must prepare a comprehensive technical file containing design and manufacturing information, pay applicable registration fees, and commit to post-market surveillance to report any adverse events related to the device. Overall, meeting these requirements is essential for successfully bringing medical devices to market in Egypt, and consulting the EDA's official resources or local experts can further facilitate the process.