The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.

Journal Article (Review;Journal Article)

Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; rs =0.90) and years of freedom from colonization (rs =0.60), and less positively correlated to GDP per capita (rs =0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.

Full Text

Duke Authors

Cited Authors

  • Hubner, S; Maloney, C; Phillips, SD; Doshi, P; Mugaga, J; Ssekitoleko, RT; Mueller, JL; Fitzgerald, TN

Published Date

  • March 2021

Published In

Volume / Issue

  • 9 / 1

Start / End Page

  • 136 - 148

PubMed ID

  • 33764886

Pubmed Central ID

  • PMC8087432

Electronic International Standard Serial Number (EISSN)

  • 2169-575X

International Standard Serial Number (ISSN)

  • 2169-575X

Digital Object Identifier (DOI)

  • 10.9745/ghsp-d-20-00578


  • eng