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’s clinical...

Malaysia has achieved a significant milestone in global medical device regulation. The Medical Device Authority (MDA), a ministry of the Ministry of Health Malaysia, has announced that its Chief Executive Officer, Dr Muralitharan Paramasua , has been elected as the Chair of the Global Harmonisation Working Party (GHWP) for the 2026–2028 term. The appointment was confirmed during the 29th GHWP Annual Meeting, held from December 1 to 4, 2025, in Bangkok, Thailand . Dr Muralitharan received...

On 4 December 2025 , the Medical Device Authority (MDA) of Malaysia published a draft guidance document titled “ Definitions of Medical Devices” and opened a public comment period from 4 to 18 December 2025. This draft guidance aims to clarify the classification of medical devices, including what constitutes a “device,” as well as definitions for accessories, components and spare parts areas that have often caused uncertainty in regulatory submissions. This is a significant regulatory...