Year: 2025
Type: article
Abstract: Regulating medical devices is essential to guarantee their safety, effectiveness, and quality. While developed countries have established robust regulatory frameworks, many developing countries, including Nigeria, face challenges in regulating both imported and locally manufactured medical devices. This article explores the regulatory framework of medical devices in developed countries using the case of Medical Device framework in the EU and FDA in US. An overview of medical device regulations in African countries was also provided, with the most focus on NAFDAC and SON in Nigeria. We found that while Nigeria has made progress in strengthening its regulatory framework, it still faces challenges in enforcement, compliance, and aligning with international standards. In addition, the intellectual property landscape and potential conflicts of interest in collaborations with industry players also require attention with the advent of medical devices locally produced in the country. Future directions include; enhanced training of personnel and alignment with international standards. reforms focusing on technological advancements, and collaborative efforts among stakeholders to guarantee the security and efficacy of medical devices.
Authors: Oyebola Oni, Ifeanyi Ogbodo, Joseph Agboola, Ayodele James Oyejide
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4409746479