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

Hubner, Sarah; Maloney, Caroline; Phillips, Sarah Dunn; Doshi, Pratik; Mugaga, Julius; Ssekitoleko, Robert T.; Mueller, Jenna L.; Fitzgerald, Tamara N.

doi:10.9745/ghsp-d-20-00578

Cited by 19 publications

(57 citation statements)

References 24 publications

(31 reference statements)

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“…Participants in the focus group discussion were selected through purposive sampling. Through literature ( 1 , 2 , 9 ) and knowledge of the local regulatory bodies in Uganda, the researchers enlisted key departments in the bodies that participated specifically in medical device regulation. Department heads and representatives were formally invited to the discussion through their supervisors.…”

Section: Methodsmentioning

confidence: 99%

“…Similarly, the medical device regulations 2017/745 of the European union provide for a four-class risk classification scheme for medical devices, a Conformité Européenne (CE) marking requirement, and a system of notified bodies to regulate safety and marketing of medical devices ( 6 ). Conversely, medical device regulation in developing countries, especially in Africa, is not well developed and is characterized by high degrees of variability and irregularity ( 7 – 9 ).…”

Section: Introductionmentioning

confidence: 99%

“…For example, Uganda, which has recorded the third highest number of clinical trials in various reviews ( 25 – 27 ) has made efforts to harmonize medical device classification and regulations (1). Controls for the importation and registration of devices have also been instituted by the National Drug Authority of Uganda ( 9 ) and capacity has been developed for clinical trials for devices applicable to malaria, HIV and Tuberculosis (2). However, there is still a lot to be done in streamlining and strengthening the regulatory pathway for IMDs in Uganda.…”

Section: Introductionmentioning

confidence: 99%

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Systems and processes for regulation of investigational medical devices in Uganda

Mpaata

Matovu

Takuwa

et al. 2023

Front. Med. Technol.

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BackgroundIn many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices.AimTo evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda.MethodsA mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology.ResultsA total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were “developing standards for medical devices regulation” and “implementation of regulations in practical processes”. Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations.ConclusionsEfforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Systems and processes for regulation of investigational medical devices in Uganda

Mpaata

Matovu

Takuwa

et al. 2023

Front. Med. Technol.

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“…RECs could expand their inclusion criteria to include a varied technical expertise such as biomedical engineers since there is a strong biomedical engineering program at local universities such as Makerere University ( 17 , 20 , 21 ). In addition to developing a formalised framework, biomedical entities, such as universities, should reach out to RECSs to provide access to appropriate expertise as needed which diversify the board's expertise to holistically evaluate applications not only from the clinical perspective, but also from a technical feasibility and design quality perspective ( 25 ) as biomedical engineers are trained to do.…”

Section: Discussionmentioning

confidence: 99%

“…According to the World Health Organisation (WHO), a clear and robust regulatory framework is necessary to guarantee public health, safety, and performance of imported medical devices and those locally manufactured ( 24 ). Although there is a presence of national regulatory bodies for medicines and health products in most African countries ( 25 ), a review of regulatory bodies for ten African countries including Uganda ( 26 ), found that these bodies are primarily concerned with regulation of imported medical devices and medicines, as opposed to locally made devices. The National Drug Authority (NDA), a Ugandan regulatory body for example, has elaborate guidelines for introducing new locally manufactured pharmaceutical products onto the market that detail requirements for production, testing, packaging, and licensing ( 27 ).…”

Section: Introductionmentioning

confidence: 99%

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

Nakandi

Muhimbise

Djuhadi

et al. 2023

Front. Med. Technol.

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ObjectiveA 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, medical device innovators and designers face challenges around bringing a device from ideation to being market-ready. This is mainly attributed to a lack of clear regulatory procedures among other factors. In this paper, we illustrate the current landscape of investigational medical devices regulation in Uganda.MethodsInformation about the different bodies involved in regulation of medical devices in Uganda was obtained online. Nine medical device teams whose devices have gone through the Ugandan regulatory system were interviewed to gain insights into their experiences with the regulatory system. Interviews focused on the challenges they faced, how they navigated them, and factors that supported their progress towards putting their devices on the market.ResultsWe identified different bodies that are part of the stepwise regulatory pathway of investigational medical devices in Uganda and roles played by each in the regulatory process. Experiences of the medical device teams collected showed that navigation through the regulatory system was different for each team and progress towards market readiness was fuelled by funding, simplicity of device, and mentorship.ConclusionMedical devices regulation exists in Uganda but is characterised by a landscape that is still in development which thereby affects the progress of investigational medical devices.

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

et al. 2023

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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 for limited access are technological, economic and social. With the advancement of MRI technology, we explore why these challenges still prevail, highlighting the importance of MRI as the epidemiology of disease changes in LMICs. In this paper, we establish a framework to develop MRI with these challenges in mind and discuss the different aspects of MRI development, including maximising image quality using cost‐effective components, integrating local technology and infrastructure and implementing sustainable practices. We also highlight the current solutions—including teleradiology, artificial intelligence and doctor and patient education strategies—and how these might be further improved to achieve greater access to MRI.

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

Cited by 19 publications

References 24 publications

Systems and processes for regulation of investigational medical devices in Uganda

Systems and processes for regulation of investigational medical devices in Uganda

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

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

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