The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.
Journal
Global health, science and practice
ISSN: 2169-575X
Titre abrégé: Glob Health Sci Pract
Pays: United States
ID NLM: 101624414
Informations de publication
Date de publication:
31 03 2021
31 03 2021
Historique:
received:
07
10
2020
accepted:
10
02
2021
pubmed:
26
3
2021
medline:
26
10
2021
entrez:
25
3
2021
Statut:
epublish
Résumé
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; r
Identifiants
pubmed: 33764886
pii: GHSP-D-20-00578
doi: 10.9745/GHSP-D-20-00578
pmc: PMC8087432
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
136-148Informations de copyright
© Hubner et al.
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