Regulating Artificial Intelligence as a Medical Device (AIaMD) in Africa: The Role of Regulatory Sandboxes in Bridging Current GAPS

Africa’s medical device industry is undergoing exponential growth. It was valued at about $4.26 billion (USD) in 2025, with projections that it will grow to $7.14 billion by 2032, significantly outpacing global averages. The increased technological advancements in medical devices, driven by artificial intelligence (AI) and the continent’s desire to increase access to treatment have provided fertile ground for this growth and expansion, with diagnostics and digital health devices showing the fastest growth. The increasing integration of AI into medical devices presents significant opportunities as well as regulatory challenges. As AI‐enabled medical devices continue to evolve and be integrated into healthcare, safeguarding safety, performance and security becomes increasingly critical. However, the regulatory landscape for medical devices in Africa is lagging. While regulation in many high‐income countries has advanced to deal emerging changes in the industry, such as software as a medical device (SaMD), in vitro diagnostics, and AI as a medical device (AIaMD), this is not the case in most of Africa. The 2016 African Union (AU) Model Law on medical product regulation, which was designed to strengthen oversight of medical products, promote regulatory harmonisation and strengthen national regulatory systems, faces several limitations which have constrained its implementation and impact. Without a harmonised legal framework among African states, many countries depend on outdated, drug‑focused legislation or must adopt external regulatory models. This raises concerns about Africa’s ability to develop competitive, context‑appropriate systems for medical‑device oversight in the era of AIaMD. Against this background, the paper analyses medical device regulation (MDR) in Africa. Using Uganda as a case study, it demonstrates that the current regulatory framework is not equipped to handle the complexity and pace of innovation in health technologies, specifically, AIaMD. It highlights the current deficiencies and explores the potential for regulatory sandboxes for AIaMD. Drawing on an example from the United Kingdom’s AI Airlock sandbox, the paper proposes the adoption of a regulatory sandbox framework as a vital bridge to foster innovation and experimentation in Africa pending regulatory reform.