Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in africa: a review of current literature
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Date
2024
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Western cape
Abstract
Medical 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
Description
Masters of Science
Keywords
Medical device, Regulations Regulatory, Harmonization