An overview of the medical device regulations in the Arab Republic of Egypt

English

Abstract:

Ilona Putz provides a comprehensive overview of the medical device regulatory framework in the Arab Republic of Egypt, outlining the structure, responsibilities, and procedures governed by the Egyptian Drug Authority (EDA). Established under Law No. 151 of 2019, the regulatory system defines requirements for classification, registration, importation, distribution, and post-market surveillance of medical devices based on a risk-proportionate model aligned with European rules. It details the roles of the EDA, including licensing, market authorisation, inspection, and vigilance activities, as well as the procedural requirements for manufacturers, importers, and Egyptian Registration Holders. The article also explains documentation requirements, approval timelines, fees, labelling rules, and lifecycle management processes, providing stakeholders with a practical guide to navigating regulatory compliance in Egypt’s evolving medical device sector.

Learning objectives:

After reading this article, readers should be able to understand:

• the legal and institutional framework governing medical device regulation in Egypt;
• the risk-based classification system for medical devices, which is aligned with the classification principles of Regulation (EU) 2017/745;
• the key requirements for manufacturers, importers, distributors, and Egyptian Registration Holders operating in Egypt;
• the procedures for medical device registration, importation, and approval, including required documentation;
• the various import approval pathways and conditions for specialised categories such as research, training, and high-risk devices;
• the labelling, packaging, and language requirements for medical devices placed on the Egyptian market;
• the post-market obligations, including vigilance reporting, incident timelines, and recall responsibilities;
• the processes for variation and renewal of registered medical devices;
• the overall regulatory timelines, fees, and appeal mechanisms within the Egyptian system.

About the author:

Ilona Putz is the owner of PULONA Emerging Markets FZE, United Arab Emirates. With over 25 years of experience in the Middle East, PULONA offers a wide range of professional services to companies in the pharmaceutical, medical equipment and medical supplies sectors. PULONA has an established network of distributors across the region that can provide optimum sales, marketing and customer services to its clients.

Specification:

14 pages plus covers, in English, supplied by email as a PDF.

This article will be published in the August 2026 issue of the Journal of Medical Device Regulation.