NAFDAC REGULATION OF AI-POWERED MEDICAL DEVICES IN NIGERIA: ADEQUACY AND REFORMS

Abstract

AI-powered medical devices are being actively deployed across Nigerian hospitals, clinics, and telemedicine platforms, yet the National Agency for Food and Drug Administration and Control (NAFDAC) has not developed a regulatory framework specifically calibrated to their unique safety, accuracy, and accountability requirements. This article critically examines the adequacy of NAFDAC's existing medical device regulatory architecture — including the 2024 Regulations and the draft 2025 Regulations — for governing AI-powered medical devices. Drawing on doctrinal legal analysis and comparative insights from the United States FDA,, South Africa's SAHPRA, Kenya, and the IMDRF international standards framework, the article identifies critical regulatory gaps including the absence of AI-specific SaMD classification criteria, no mandatory pre-market AI accuracy validation, inadequate post-market surveillance for algorithmic drift, absent algorithmic transparency requirements, and no algorithmic bias assessment obligations. The article proposes a targeted reform agenda anchored in AI-specific SaMD regulations, mandatory pre-market validation, the establishment of an AI Medical Device Advisory Committee, enhanced post-market surveillance, and alignment with IMDRF international standards. It concludes that regulatory adequacy for AI medical devices is a patient safety and human rights imperative that NAFDAC must urgently address.