The article from MedicalBrief highlights the rapid integration of artificial intelligence (AI) into medical devices. This includes AI programs for cancer detection in MRIs and brain implants restoring speech. It underscores the regulatory challenges faced by authorities, internationally, in ensuring the safety and efficacy of these advanced technologies.
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulation of medical devices, including those incorporating AI. SAHPRA license medical device establishments and will later register medical devices for use in South Africa. The purpose of regulation is to ensure medical devices are safe, of quality, and effective.
However, the current regulatory framework in South Africa is not be equipped to address existing technology, let alone the unique challenges posed by AI-driven medical devices.
Existing legislation generally is considered outdated for reviewing AI-based technologies, and there is a need for a proper framework to approve and regulate autonomous and adaptive AI-based medical devices.
To address these challenges, it is recommended that South Africa: