Developing a National Biomedical Engineering Registration and Licensing Framework for Nigeria: A Policy Development Study

The absence of a statutory registration and licensing framework for biomedical engineers in Nigeria creates significant patient safety risks, as the practice of clinical engineering remains unregulated with no defined entry competency standards, continuing professional development requirements, or professional accountability mechanisms. This study develops a policy framework for national biomedical engineering registration and licensing in Nigeria, drawing on comparative analysis of professional regulation models in South Africa, United Kingdom, and the United States, combined with extensive national stakeholder consultation. Stakeholder consultation involved structured interviews with fifty practising biomedical engineers, regulatory affairs professionals from NAFDAC and the Federal Ministry of Health, university department heads, and clinical hospital directors across all six geopolitical zones. Comparative regulatory analysis examined scope of practice definitions, entry qualification requirements, registration examination structures, continuing professional development frameworks, and disciplinary procedures in each reference country, identifying elements transferable to the Nigerian context. The proposed framework specifies three registration categories: graduate biomedical engineer, specialist clinical engineer, and biomedical engineering technologist. Entry requirements, examination syllabi, annual continuing professional development point requirements, and a disciplinary tribunal structure are defined for each category. A home body governance proposal is developed for a Biomedical Engineering Registration Board of Nigeria under the FORTAS Act framework. Implementation phasing over a five-year period is proposed with cost analysis. The framework was refined through a national stakeholder review workshop before finalization. Keywords: biomedical engineering registration, professional licensing, Nigeria, policy framework, clinical engineering.