Egypt's medical device market is experiencing a significant surge, driven by ambitious government initiatives to modernize healthcare infrastructure, a growing population, and a strategic push towards local manufacturing. This vibrant sector is attracting considerable investment and innovation, positioning Egypt as a key player in medical technology for the wider Middle East and Africa (MEA) region.

Market on a Growth Trajectory

The Egyptian medical devices market, estimated at approximately $4.24 billion in 2023, is projected to reach $5.37 billion by 2031, demonstrating a steady Compound Annual Growth Rate (CAGR) of 3.10%. This growth is underpinned by several factors:

• Increased Healthcare Expenditure: The Egyptian government is significantly boosting its healthcare budget, with a focus on improving accessibility and quality of services. This includes substantial investments in new hospitals and healthcare facilities, creating a robust demand for medical devices to equip these expanding infrastructures.
• National Health Insurance Program: The ongoing implementation of a new National Health Insurance program is set to ensure universal access to medical insurance, further increasing the demand for medical devices and services across the population.
• Growing Demand for Advanced Technologies: There's a rising need for innovative and technologically advanced medical devices, such as robotic surgery systems, telemedicine solutions, and remote patient monitoring devices, to enhance patient outcomes and healthcare delivery efficiency.
• Medical Tourism: Egypt's growing reputation as a destination for medical tourism, offering high-quality and affordable healthcare, also contributes to the demand for cutting-edge medical equipment.

Strategic Push for Local Manufacturing

A key trend dominating the news is Egypt's concerted effort to localize medical device manufacturing. This strategic initiative aims to reduce import dependency, enhance self-sufficiency, and establish Egypt as a manufacturing hub for the region.

• Philips Partnership: In a landmark move on May 27, 2025, Egypt's Ministry of Health and Population signed a cooperation protocol with global tech giant Philips to localize the medical device industry. This agreement includes feasibility studies for domestic production, development of device components, and the establishment of a specialized biomedical engineering knowledge transfer center, aiming to significantly increase the presence of Egyptian-made products.
• Government Support: The government is actively promoting investment in local production, with discussions on financing initiatives and streamlined land allocation procedures for new projects. The Unified Procurement Authority (UPA) is also playing a role in recommending the localization of medical raw materials and device industries.
• Investment Opportunities: Significant opportunities exist for investors in high-tech medical devices, particularly in areas like diagnostic imaging and consumables, which constitute large segments of the market. Egypt's strategic location, competitive labor costs, and various free trade agreements make it an attractive manufacturing base for exports to North Africa, Sub-Saharan Africa, and the Middle East.

Evolving Regulatory Landscape

The Egyptian Drug Authority (EDA) is the primary regulatory body overseeing medical devices, focusing on ensuring safety, quality, and efficacy. Recent developments highlight efforts to refine and enforce regulations:

• Decree 39 of 2025: Effective July 1, 2025, this decree sets new guidelines for the importation and handling of medical products, prohibiting the import of finished products with less than two-thirds of their total shelf life remaining upon arrival. This measure aims to safeguard public health and ensure pharmaceutical security.
• Advertising Guidelines: The EDA has also issued new guidelines for advertising and promotion of medical devices, emphasizing truthfulness, consistency with intended use, and the need for prior approval for most advertising materials.
• Registration Process: All medical devices require registration with the EDA and must obtain Marketing Authorization. Manufacturers without a local presence in Egypt must appoint an Egyptian Registration Holder. The registration process can take 6-12 months, and licenses are valid for 10 years.

Challenges and Opportunities

Despite the positive outlook, the Egyptian medical device market faces challenges, including:

• Import Dependency: The market remains largely reliant on imports (nearly 90%), particularly for high-tech equipment. This makes it vulnerable to currency fluctuations and supply chain risks.
• Regulatory Complexity: While efforts are being made to streamline processes, bureaucratic red tape and lengthy approval times can still hinder market entry.
• Limited Healthcare Budget: Despite increased expenditure, the overall healthcare budget can still be a limiting factor in the purchasing power of healthcare providers.

However, the opportunities far outweigh the challenges. Egypt's growing population, increasing health awareness, government commitment to universal health coverage, and strategic drive for local manufacturing paint a promising picture for the medical device sector in the coming years. Tender opportunities for maintenance and supply of medical equipment, such as the recent tender for Al Azhar University Hospital, continue to emerge, indicating ongoing investment in healthcare infrastructure.