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FDAnews Device Daily Bulletin

South Africa New Device Regs Are Now Live

June 22, 2017

As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics.

The new independent state-owned regulatory entity is called the South African Health Products Regulatory Authority (SAHPRA) and will regulate both drugs and devices.

The agency began grandfathering devices and IVDs into the new system in February, and that implementation period will end on Aug. 24, according to the South African Medical Device Industry Association (SAMED). After the implementation ends, companies wanting to sell their devices in South Africa will need to license their products.

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