Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.
clinical trials
health technical assessment
investigational medical devices
medical device regulations
medical devices
medical innovations
Journal
Frontiers in medical technology
ISSN: 2673-3129
Titre abrégé: Front Med Technol
Pays: Switzerland
ID NLM: 101772626
Informations de publication
Date de publication:
2022
2022
Historique:
received:
25
05
2022
accepted:
05
07
2022
entrez:
15
8
2022
pubmed:
16
8
2022
medline:
16
8
2022
Statut:
epublish
Résumé
Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.
Identifiants
pubmed: 35968546
doi: 10.3389/fmedt.2022.952767
pmc: PMC9368574
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
952767Subventions
Organisme : Medical Research Council
ID : MR/T03937X/1
Pays : United Kingdom
Informations de copyright
Copyright © 2022 Matovu, Takuwa, Mpaata, Denison, Kiwanuka, Lewis, Norrie, Ononge, Muhimbise, Tuck, Etuket and Ssekitoleko.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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