The Nigerian pharmaceutical manufacturing sector holds significant importance for Nigeria's economy, particularly in relation to medical devices. Extensive research conducted on the Nigerian medical device industry has highlighted numerous challenges that hinder the sector's development. This study aims to investigate the challenges faced by the Nigerian pharmaceutical industry, with emphasis on the regulation and quality aspects of medical devices. Usar et al. (2017, p. 86-91). emphasize the weak state of pharmaceutical regulation in Nigeria, characterized by irregular inspections, inadequate enforcement, widespread violations, and resultant negative health outcomes. To structure the research process, the study adopts the Research Onion framework proposed by Saunders, Lewis, and Thornhill in 2009. The interpretivist research philosophy plays a central role in this dissertation's context. Employing a deductive research approach, the study aims to collect data and formulate a theory based on the obtained results Saunders et al. (2019, p. 207). A case study strategy is employed to gain in-depth understanding of the challenges, particularly in the regulatory and quality aspects, faced by the two selected medical device manufacturing firms and the regulatory authorities that restrict their performance. The research design involves a mono-method approach for data collection. The gathered data is then analyzed thematically, contributing to the overall research findings. The study reveals significant weaknesses in the current regulatory framework for medical devices, including poor implementation of guidelines, lengthy processing times, and inadequate post-marketing surveillance. Regarding challenges related to the manufacturing of high-quality medical devices, the study identifies the lack of raw materials and the unavailability of custom-made machine parts as key factors affecting the production capabilities of medical device manufacturing firms in Nigeria. Insufficient funding, policy inconsistencies, regulatory duplication, and high inspection costs are identified as factors contributing to the ineffectiveness of medical device regulation and registration. Finally, in terms of the efficacy of quality and safety management practices, the study concludes that the existing practices are inadequate in ensuring the utmost safety of the public.