Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework

N Nasir, S Molyneux, F Were, A Aderoba… - BMJ Global Health, 2023 - gh.bmj.com
Regulatory and other governance arrangements influence the introduction of medical
devices into health systems and are essential for ensuring their effective and safe use …

[HTML][HTML] 6-month migration sufficient for evaluation of total knee replacements: a systematic review and meta-analysis

R Puijk, RH Puijk, EK Laende, MJ Dunbar… - Acta …, 2023 - ncbi.nlm.nih.gov
Background and purpose This updated meta-analysis evaluates the migration pattern of the
tibial component of primary total knee replacements measured with radiostereometric …

[HTML][HTML] Experiences of medical device innovators as they navigate the regulatory system in Uganda

BT Nakandi, O Muhimbise, A Djuhadi… - Frontiers in Medical …, 2023 - frontiersin.org
Objective: A medical device must undergo rigorous regulatory processes to verify its safety
and effectiveness while in use. In low-and middle-income countries like Uganda however …

[HTML][HTML] Systems and processes for regulation of investigational medical devices in Uganda

CN Mpaata, B Matovu, M Takuwa… - Frontiers in Medical …, 2023 - frontiersin.org
Background In many parts of the world, medical devices and the processes of their
development are tightly regulated. However, the current regulatory landscape in Uganda …

E-sisters and the case of the Essure coil: power, representation, and voice in women's public docket accounts to the FDA of medical device adverse events

EA Hintz, J Applequist - Journal of Applied Communication …, 2023 - Taylor & Francis
One in ten US patients has an internally implanted medical device. Yet, lax regulation by the
US Food and Drug Administration (FDA) has resulted in the approval of medical devices …

Gaps and priorities in innovation for children's surgery

TN Fitzgerald, A Zambeli-Ljepović, BT Olatunji… - Seminars in Pediatric …, 2023 - Elsevier
Lack of access to pediatric medical devices and innovative technology contributes to global
disparities in children's surgical care. There are currently many barriers that prevent access …

Lifecycle of surgical devices: Global, environmental, and regulatory considerations

ER Wahlstedt, JC Wahlstedt… - World Journal of …, 2024 - Wiley Online Library
Background Technological advancements, improved surgical access, and heightened
demand for surgery have fueled unprecedented device and supply turnover impelling …

The Localisation of Medical Manufacturing in Africa

G Banda, J Mugwagwa, M Mackintosh, A Mkwashi - 2022 - oro.open.ac.uk
This report emanates from a study commissioned by the Institute for Economic Justice (IEJ),
a South African-based think tank. It was carried out between August 2021 and September …

Bringing MRI to low‐and middle‐income countries: directions, challenges and potential solutions

S Murali, H Ding, F Adedeji, C Qin… - NMR in …, 2023 - Wiley Online Library
The global disparity of magnetic resonance imaging (MRI) is a major challenge, with many
low‐and middle‐income countries (LMICs) experiencing limited access to MRI. The reasons …

Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study

CA Ikwuegbuenyi, LN Lohkamp… - Expert Review of …, 2023 - Taylor & Francis
Introduction Spinal implants play a vital role in healthcare delivery, and regulations are
necessary to ensure their quality, approval, access, and use. In this article, we examine the …