Nkuku, Khanyisile Zachia2024-11-042024-11-042024https://hdl.handle.net/10566/17103Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries. This study examined the feasibility of establishing an African-based equivalent of Conformitè Europëenne mark (CE mark) with a similar standard to that in Europe for indigenous African medical device manufacturers. The study also explored how such African-based CE mark will encourage innovation and expand access to medical devices in Africa.enMedical deviceRegulatory HarmonizationRegulatory ConvergenceConformitè Europëenne MarkAfricaThesis