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...