Ncube, Bakani MarkDube, AdmireWard, Kim2023-02-282023-02-282023Ncube, B. M. et al. (2023). The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges. Frontiers in Medicine, 10, 1117439. https://doi.org/10.3389/fmed.2023.11174392296-858Xhttps://doi.org/10.3389/fmed.2023.1117439http://hdl.handle.net/10566/8468In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States.enPharmaceutical policyAfrican medicinesLegislationMedical healthAfrican UnionArticle