Medical devices in South Africa are now regulated by the newly established South African Health Products Regulatory Authority (SAHPRA), which has replaced the Medicines Control Council (MCC).
The new regulator was appointed following the introduction of the Medicines and Related Substances Amendment Act (2008), which came into force on June 1, 2017.
SAHPRA, which also regulates complementary medicines, supplements and radiation control, will clear the backlog of applications awaiting registration by the MCC and streamline all regulatory processes. Contact us today
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