Medical devices play an essential role in clinical decision-making processes and improvement of patient outcomes (1, 2). This contributes to achieving key performance indicators and targets such as in the United Nations Sustainable Development Goal of good health and well-being (SDG3) (3). However, healthcare facilities in low- and middle-income countries (LMICs) have limited access to functional essential medical devices (4, 5). A study assessing access to essential technologies for safe childbirth in LMICs showed that 40% of medical equipment were non-functional compared to high-income countries (HICs), with less than 1% non-functional medical equipment (6). This disparity stems from a reliance on imported equipment in LMICs hospitals—80% of which is donated (7)—and insufficient training for proper use and maintenance (8–10). In turn, this renders equipment unreliable to provide timely diagnosis, prevention, monitoring, and treatment of disease, thus accentuating inequities in overall health outcomes (2), which contribute to the high mortality rates in LMICs (11, 12).

This gap can be tackled, in part, by developing internal systems in LMICs in order to decrease the dependence on imported medical technology, especially during grim situations such as COVID 19. When COVID-19 was announced as a global pandemic in March 2020 (13), several HICs banned export of critical care medical equipment such as mechanical ventilators and patient monitors (14), leaving many LMICs that rely heavily on imported medical devices unable to manage critical COVID-19 patients adequately.

While COVID-19 exacerbated the consequences of reliance on imported medical devices, inadequate access to medical devices in LMICs is not a new issue has continually attracted interest on global health platforms (15). Some scholars suggest the design of frugal but appropriate devices as the most optimal solution to this pressing need (16). In Uganda, efforts in this direction are starting to show promise. An increasing number of innovations developed locally, sometimes as part of international teams are emerging (17), signalling a possible shift from overdependence on health technology from HICs. This is driven in part by an increase in Ugandan institutions training biomedical engineers, targeted funding from both international organisations such as the UK Medical Research Council (18) and Grand challenges Canada (19), as well as local funders such as Makerere University Research Innovation Fund (20, 21) and the Ugandan Ministry of Science & Technology (22).

In Uganda to date, only low-risk, locally-manufactured devices like incinerators (23) have reached market readiness. One of the leading causes for this is the lack of a clear regulatory framework and pathway for investigational medical devices (IMDs). 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).

Due to uncertainties regarding how to navigate the regulatory system, innovators who seek approval for their IMDs in Uganda tend to follow more established regulatory systems such as the USA Food & Drug Administration's (FDA) Centre for Devices & Radiological Health Regulations or the European Union (EU) CE marking regulations. NDA allows for products that are already approved from recognized reference markets (such as in International Medical Device Regulators Forum countries) to leverage these approvals via an expedited review in Uganda. Under this arrangement, a local manufactured IMD that has obtained such approvals can be licensed (28). However this comes with drawbacks (29) such as prohibitively expensive costs related to ensuring compliance and application fees (30), and limited knowledge within the local innovator community of navigating these foreign regulatory systems.

For devices that do not have any foreign approvals, the pathway to approval in Ugandan markets is not well known. Thus, the aim of this paper is to explore, understand, and evaluate the existing Ugandan medical device regulatory systems by interviewing local IMD innovators that have navigated the system and approval process.

The material for this report was collected primarily from employing two sources: (1) Review of public information regarding device regulation and (2) innovators' reports of their experiences with developing new medical devices in Uganda.

Sources of information about medical regulation: A search was undertaken to find publicly accessible information about medical device regulation in Uganda. Specific websites from relevant bodies such as the Uganda Ministry of Health, Uganda National Bureau of Standards (UNBS), and NDA, among others, were examined. From these sites, we were able to conduct background research on all existing regulatory bodies in Uganda to establish the roles played by each body in the regulatory landscape.

Innovators: Technologies at various stages along the pathway to market readiness were identified from the networks of the authors. The criteria for inclusion in this discussion were: •

A device solving a local health care challenge, and developed for the Ugandan market, regardless of the origin or nationality of innovators or manufacture;

We identified nine projects that covered a broad spectrum of areas including diagnosis, therapeutics and monitoring Each team, as shared by interviewees, composed of at least 3 members from different professional backgrounds including engineering, medical fields, and business management. None of the teams interviewed had progressed to market approval, so we could only analyse the stages prior to market approval. Table 1 below lists the teams interviewed, their affiliations, year founded, country of origin, the problem being solved, and proposed solution.

The results of our investigation illustrate a nascent medical devices regulatory landscape in Uganda. There are multiple institutions with regulatory oversight over the development and importation of medical devices in the country. However, experiences of medical technology innovation teams demonstrate a lack of clarity in the roles of these regulatory bodies, and in some cases, overlapping mandates. Because Uganda has yet to establish a formalised regulatory pathway for biomedical products, the guidance the teams received did not always recommend the same path. All teams identified that the lack of public information about which regulatory body to approach first was a significant obstacle in navigating the regulatory pathway in Uganda. Some bodies did not clearly state their roles or had different sources providing contradictory information, which contributed to the confusion. As is common in sub-Saharan African countries (43, 44), Uganda has established basic regulatory systems that lack the capacity to execute higher-end medical device approvals. WHO recommends that local innovators need to be informed and educated about the regulatory system and its requirements (45). This can be incorporated in a formalised pathway for the regulation of IMDs in Uganda. Such a pathway may best be developed using a multi-sector approach whereby academic institutions, the health sector, and regulatory bodies within the country partner to develop the regulatory pathway.

Alternatively, Uganda could take the approach of the USA whereby regulation of medical devices (both imported and locally manufactured) is entirely administered by one body, the FDA. The FDA issues different types of approval for medical devices depending on the level of risk to the users (46). Manufacturers of low risk or Class I devices must self-certify and register their device on the FDA website before launch to market. Authorisation to market medium risk or Class II devices is issued by the FDA in form of a 510 (k) premarket notification and this is granted after submission of an application that evidences that a device is safe and effective (46). The application is required to demonstrate significant equivalence to a predicate device, already on the market (46). Class III devices or high-risk devices undergo the most stringent scrutiny. Manufacturers are required to participate in pre-approval audit of manufacturing facilities and Quality Management Systems with the FDA. They must submit documentation of results on non-clinical trials, clinical trials, safety, and effectiveness data. Before a prerequisite clinical trial is carried out, an Investigational Device Exemption (IDE) must be sought from the FDA (46). At the end of these processes the FDA issues Premarket Approval for successful applications for Class III devices (46). For avoidance of lack of clarity and overlap of mandate, Uganda could take this approach whereby the National Drug Authority would fully sanction the regulation of medical devices and create regulatory pathways for medical devices that are disaggregated by classes.

Innovators identified the need for a central point to access all information about regulation similar to what is enacted by well-established bodies like the FDA in the US, the Therapeutic Goods Association in Australia, or the Therapeutic Products Directorate in Canada. According to the Ugandan Public Health Act(45) (47), the body responsible for overseeing the health delivery system in Uganda is the MOH. This paper highlights the need for focused efforts by the MOH and other regulatory bodies to develop and provide explicit and comprehensive information concerning the medical devices regulatory framework in Uganda and make it readily available for innovators and researchers to design their studies appropriately before review. This framework should be published online, distributed to common resources like innovator hubs, in addition to being incorporated into the curriculum for science and technology students. Teaching about the regulatory process within Uganda could be a complementary component of university education in translational health technologies and their applications (48).

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.

Regarding the lack of standards for some IMDs, development of medical device standards is a tedious and financially demanding process. With a collaborative strategy, however, combined efforts amongst all stakeholders in the medical device design process can yield contextualised standards that are easily accessible to local innovators (45). In order to increase the ability of locally developed products to reach market readiness, the Ugandan government should be encouraged to provide funds to adopt and tailor already existing international standards like ISO 16142-2:2017 (49) for medical devices intended for the local market. This can be done along with collaboration between leading academic institutions and hospitals that can lend their expertise and insight to ensure these standards assess the safety and effectiveness of new technologies.

There are several limitations with our study. First, the scope of this study focused on interviewing the experience of innovators that attempted to seek medical device approvals in Uganda but did not include engaging representatives of said bodies that are involved in the regulation. Speaking directly to these bodies to elucidate their perspectives of the order of events to seek approval, how they use the recommendation and evaluation of other bodies when assessing proposals, and their general suggestions to innovators on how to achieve approval from their office would have greatly enhanced the study. Second, none of the innovator teams had accomplished obtaining medical device approval at the time of interviewing which limits the study by not having a complete case that has reached market entry as a model for which other innovators could follow. Third, innovators had not obtained approval for these products elsewhere in foreign markets either. And so, this study is limited to focusing on track three of medical device approval as opposed to track one and two, which is for products pre-approved in other countries (41).

In conclusion, although there is some form of regulation of IMDs in Uganda, there is a lack of clarity about the steps and standards to follow while seeking approval. Therefore, this discrepancy presents a need for a formalised and established regulatory framework agreed upon by all bodies and widely understood by stakeholders involved with innovation of locally-designed medical technologies. It would be very helpful if local bodies undertook a benchmarking exercise in jurisdictions where IMDs are comprehensively regulated such as in the USA, EU or Canada. Such a framework would be an essential part of the innovation ecosystem which positively impacts the delivery of health care services in Uganda.

To understand the steps and key players involved in ensuring safety and quality of innovative medical technologies before they reach the market in Uganda, we interviewed nine medical technology teams undergoing the process. In this paper, we share their experiences, the challenges they faced, and what enabled them to overcome those challenges.