Egypt Medical Device Industry News Roundup

Government Focuses on Local Manufacturing and Partnerships:

Egypt is actively pursuing strategies to strengthen its local medical device manufacturing capabilities. The Chairman of the Healthcare Authority recently met with industry leaders to discuss enhancing local production and localizing the manufacturing of medical devices and diagnostic supplies. A cooperation protocol is expected to be signed to further these goals, including improving the competency of laboratory personnel.

In a significant move towards self-sufficiency, the Deputy Minister of Health oversaw the signing of a cooperation protocol to establish Egypt's first factory for ultrasound device manufacturing. This partnership between a local medical industries company and a leading Chinese manufacturer aims to reduce reliance on imports and transfer medical technology. The first locally produced ultrasound device is expected to be launched in April 2025.

International Collaborations and Market Access:

Egypt is also exploring collaborations with international medical technology companies. The Deputy Prime Minister and Minister of Health met with a regional Vice President of a major global medical device company to discuss potential cooperation in medical technology, services, and solutions. Key areas of discussion included expanding access to advanced cardiac procedures, launching a national screening program for critical congenital heart disease in newborns, and introducing deep brain stimulation technology for neurological disorders.

Recent regulatory changes are also making the Egyptian market more accessible to international companies. Foreign manufacturers can now participate in public tenders by registering with the Unified Procurement Authority (UPA). This has further opened the market, which is already the second-largest in the MENA region but heavily reliant on imports due to low local production.

Regulatory Landscape and Market Growth:

The Egyptian medical device market is experiencing steady growth, with projections indicating a CAGR of over 3% in the coming years. This growth is driven by factors such as increasing healthcare expenditure, a growing elderly population, and government initiatives to improve healthcare infrastructure, including the construction of new hospitals.

The Egyptian Drug Authority (EDA) regulates medical devices in Egypt, with registration becoming mandatory since September 2018. The classification of medical devices aligns with the European system. Foreign manufacturers need to appoint a local authorized representative to handle the registration process. Recent updates include the implementation of a new online platform for registration and temporary measures to facilitate imports while manufacturers complete full registration.

Challenges and Opportunities:

Despite the positive growth trends, the Egyptian medical device market faces challenges such as complex regulatory frameworks, lengthy approval processes, and reliance on imports, which can be affected by currency fluctuations. Limited healthcare expenditure and bureaucratic procurement procedures can also create barriers. However, the government's commitment to improving healthcare, coupled with a rising prevalence of chronic diseases and increasing demand for advanced medical technologies, presents significant opportunities for both local and international players in the Egyptian medical device market. The focus on preventative healthcare and the increasing number of private healthcare facilities are also contributing to market expansion.