Regulatory Update | September 2026 South Africa's medical-device regulatory landscape is continuing to evolve. The South African Health Products Regulatory Authority (SAHPRA) is advancing work on a more structured regulatory framework with two parallel developments signaling where the market is heading. In August 2026, SAHPRA called for an independent expert review of its Draft Medical Devices Regulations. Then, on 9 September 2026, the Authority published an addendum extendi

South Africa has taken a significant step forward in strengthening its medical device regulatory framework. On 9 September 2025 , the South African Health Products Regulatory Authority (SAHPRA) published the Guidelines on Clinical Evaluation of Medical Devices (SAHPGL-MD-16_v1). This long-anticipated update brings more clarity, structure, and global alignment to how manufacturers must demonstrate clinical evidence. This updated guideline is designed to modernise South Africa’

The South African Health Products Regulatory Authority (SAHPRA) has made significant strides in enhancing its regulatory framework for...