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African Market Entry
Unlock the Potential of the African Market
You've built your reputation internationally. Now, you can tap into one of the fastest-growing regions for medical devices. The African market represents a $4.5 billion opportunity with a 7.1% CAGR between 2024 and 2032.
We can help you leverage your existing global market access to enter Africa. The current landscape presents a unique opportunity:
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Growing Healthcare Investment: Rising government and private sector investments are expanding healthcare infrastructure and services.
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Technological Adoption: The rapid adoption of digital and mobile technology is driving demand for new medical devices, from diagnostics to health tech.
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Regulatory Reliance: Many regulatory systems across the continent use a reliance model, accepting approvals from global markets like the EU and FDA to streamline their processes.
South Africa:
the Gateway to Africa
South Africa is a significant player and a good entry point into the African market due to its advanced regulatory framework and strong economy.
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Accessing South Africa: The South African Health Products Regulatory Authority (SAHPRA) regulates medical devices and in-vitro diagnostics (IVDs) to ensure they meet acceptable standards of safety, quality, and performance.
As a medical device establishment, you are required to obtain a license from the SAHPRA Medical Devices Unit to operate as a manufacturer, distributor, or wholesaler. This license is essential for legally conducting business in South Africa, including bidding on national and provincial tenders, and demonstrates your commitment to regulatory compliance. SAHPRA is also in the process of developing a medical device registration process to further ensure product quality.
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Find out how to enter this crucial market and establish your in-country representation.
Expanding Your Reach from Africa to the World
You've successfully launched your product at home and are ready to expand your reach on a global scale. While local regulations may be less strict, navigating global markets can be overwhelming. From determining the right regulatory pathway to compiling market-specific dossiers, we offer services to help you reach your goals.