New regulation could impact SA’s medical device market

As South Africa moves towards universal healthcare with a National Health Insurance System (NHIS), this, combined with the Competition Commission’s market inquiry and further changing legislation will effect radical change to the purchasing and provision of private and public healthcare in South Africa.

Along with Egypt, South Africa accounts for 40% of the medical devices market in Africa; and with annual healthcare spend of 8.4% of GDP, South Africa’s medical device market is estimated to be worth USD1.27 billion.   With expected year-on-year growth in medical devices of over 8% between 2018 and 2024 , the increased interest in the country from local and international manufacturing companies is on the rise.

According to Ryan Sanderson, Exhibition Director of Africa Health Exhibition and Conferences, South Africa is the largest and most industrialised economy in sub-Saharan Africa and the business hub for the medical device and medical lab sector in the region. South Africa’s medical lab services market was estimated at USD$ 1.68billion. Other African nations, including Namibia, Botswana and Uganda benefit from the exports of medical devices and medical lab equipment.

The projections for economic growth of 3.5% in sub-Saharan Africa by 2019  bodes well for an associated rise in healthcare spend to address the increasing rate of non-communicable diseases, as well as to help attain health-related Sustainable Development Goals within the region. “In a region where 90% of medical devices are imported, this will benefit medical device exports and will raise the potential for both local and international businesses to develop solutions for smart and affordable disease prevention, monitoring and treatment,” Sanderson explains.

“However, issues like political uncertainty and high sales tariffs can make the region an uncertain one in which to operate,” he points out.

Annelien Vorster, Regional Sales Manager at HemoCue South Africa and exhibitor at Africa Health, believes that the rewards of doing business in Africa far outweigh the complexities.

Martha Smit, Partner at Fasken points out however that currently, each country has its own regulatory and compliance requirements and that this silo approach by the different regulatory authorities is both costly and time-consuming.

“Ultimately, we need this alignment not only for the industry to have a more controlled flow and sustainable goals for registration and going to market, but more importantly, to assist in providing much-needed healthcare and treatment for those patients who need it most”, Smit adds.

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