Healthcare overview
As of 2023, Rwanda had a population of about 14 million people and a population growth rate of 2.2 percent per year.
In 2023, Rwanda’s human development index was 0.578, placing it in the medium human development category.
The top causes of death in Rwanda are stroke, respiratory infections such as influenza and pneumonia, preterm birth complications, ischemic heart disease and malaria.
The disease pattern in Rwanda is swiftly transitioning toward NCDs. They were responsible for 30 percent of all fatalities in 2000, 39 percent by 2010 and 50 percent by 2019.
In 1999, the country introduced a community-based health insurance (CBHI/“Mutuelles de santé”) system in three health districts (Byumba, Kabgayi and Kabutare) as a pilot project.
In 2004, the government approved the policy and, in 2008, it became obligatory for all citizens.
CBHI divides households into three groups based on their economic status and has developed a tiered pricing model to co-finance the UHC scheme. Group 1 comprises the lowest-income residents (26 percent of the population); their coverage is free. Group 2 comprises 58 percent of the population; their premium is 3,000 Rwandan Francs (about USD 2) per person per year. Group 3 covers the wealthiest households (16 percent of the population) for 7,000 Rwandan Francs (about USD 5) per person per year.
According to 2019-20 Rwanda Demographic and Health Survey, about 77 percent of women and 78 percent of men between the age of 15 and 49 are covered by this insurance.
Quadrupling the healthcare workforce
In July of 2023, the government of Rwanda approved the “4x4 Reform,” a strategy aimed at quadrupling the number of healthcare workers in the country within the next four years. This reform is based on WHO’s recommendation of at least four healthcare professionals per 1,000 population density.
Interviewees highlighted several developments that have recently further improved access to affordable healthcare in the country. These include the introduction of drone delivery systems like Zipline (that are currently being used to deliver blood to patients in remote areas),
Specifically, drone delivery systems and telemedicine have proved to be excellent mechanisms to deliver last-mile healthcare. Continued support from bilateral initiatives, international organizations, public-private partnerships and non-profits has also played a crucial role.
Industrial policy
Rwanda’s National Industrial Policy is based on two main economic pillars: domestic production and export competitiveness.
In 2011, Rwanda introduced policy actions aimed at facilitating technology transfer through the restructuring of the Industrial Research and Development Agency (IRDA) in support of the transfer of innovative technologies. This led to the development of the National Industrial Research and Development Agency, which seeks to support local innovators to become competitive through technology monitoring, acquisition, development, transfer and applied research.
Subsequently, and in line with Rwanda’s National Strategy for Transformation 2017-2024,
Notably, this strategy also includes the promotion of pharmaceuticals and medical devices manufacturing. To further this, the strategy proposes to create sector-specific incentives, investment in capacity building of priority sectors and to support technology acquisition. Policies such as these can play important roles in developing the IP and innovation ecosystem required to support the development of the local MedTech sector.
Lastly, the strategy acknowledges Rwanda’s reliance on imports and recommends further industrialization to support a structural shift in its export base. For this purpose, the strategy looks to promote local manufacturing and its “Made in Rwanda” policy, which includes, among other things, the creation of a pharmaceutical production plant.
MedTech imports/exports
On average, from 2011 to 2021, total trade (imports and exports) contributed 54.2 percent to Rwanda’s GDP each year.
Rwanda imports nearly all of its medical devices and laboratory equipment.
Rwanda is also a global exporter of instruments and appliances for medical use, predominantly in Africa; key markets include the Democratic Republic of the Congo, Ethiopia, Ghana, Kenya, the Kingdom of the Netherlands, South Sudan, United Republic of Tanzania, Uganda, and the United Arab Emirates.
Rwanda has made significant strides in reducing trade and taxation barriers for medical imports and exports through regional economic free trade agreements and its domestic policies and regulations. It is a member of the East African Community, the Common Market for Eastern and Southern Africa and the African Continental Free Trade Area. It benefits from the customs union within these regional economic blocs, which serve as regional integration mechanisms. These unions facilitate the free trade of goods and services with zero duty and implement a common external tariff for imports. Additionally, they apply uniform, harmonized rules for both imports and exports.
No common external tariff rate is applied under these regional integration systems for some MedTech products, such as cameras for medical or surgical examination of internal organs, ECG machines, ultrasound machines, MRI apparatuses, X-ray machines and orthopedic and assistive care devices, such as hearing aids and wheelchairs.
The country has recently announced regulations related to licensing and authorization of imports and exports of medical devices and issued supporting guidelines.
Rwanda is establishing itself as a model by implementing strong policies, regulations and guidance to facilitate the import and export of medical devices. However, due to limited data on trade in the MedTech sector, it is challenging to fully assess the opportunities and scope for improvement in MedTech imports and exports.
Intellectual property
Rwanda stands out as an African nation that has made significant and proactive efforts to leverage IP for its economic growth. The country passed its first IP law in 1963, establishing a basic framework for IP protection.
In 2018, Rwanda revised its IP policy to enhance the protection of IP rights and strengthen the institutional framework. The updated policy aims to create an environment that supports the economic use of IP rights by innovators and businesses. It sets the following goals to encourage innovation:
Intensify awareness among IP users and potential users (including creators, innovators, potential investors, research centers and universities, small and medium enterprises and relevant government officials) of the policy and legal framework related to protection of IP rights in Rwanda;
Create a suitable environment for the advancement of scientific and technological skills that in turn would increase innovation capacity in the country;
Facilitate the development and economic exploitation of innovative and creative projects by creators, inventors, innovators and SMEs;
Comply with international treaties on IP
To accelerate industrialization and attract manufacturers and innovators, the policy suggests that Rwanda strengthen its IP framework. In the policy, Rwanda also expresses its commitment to strengthening regional and international cooperation in IP rights, aiming to reduce filing costs and increase efficiency. The country actively participates in the TRIPS Council at the WTO and seeks more engagement in WIPO, ARIPO and other UN agencies related to IP policymaking, guided by the WIPO Development Agenda and the WHO Global Strategy and Plan of Action on Public Health.
The IP Office within the Rwanda Development Board (RDB) administers registration of IP in Rwanda and related contentious (disputes such as oppositions) and non-contentious (routine registrations and administrative matters) proceedings.
Commitment to support innovation
The most recent update in Rwandan IP law occurred in July 2024, when the country replaced the 2009 law with a new law that represents a significant evolution. This reflects Rwanda’s ongoing commitment to strengthening its IP regime to support innovation and economic growth.
The 2024 IP law substantially updates and broadens the scope of the 2009 law in Rwanda and provides clearer guidance on protection and enforcement. The key highlights of the law that indicate Rwanda’s commitment to strengthening its health sector through the strategic and appropriate use of IP are as follows:
There are no changes to MedTech patentability requirements, but a key update now limits the exclusion of pharmaceutical products in the 2009 law to those specified by executive order.
(40)Art. 23, Law No. 55/2024 of 20/06/2024 on the Protection of Intellectual Property. So far, no such order has been issued. This shift signals Rwanda’s evolving public health policies and a growing focus on encouraging medical innovations.Rwanda now provides a mechanism for filing pre-grant oppositions against a published patent application by any interested person, as well as for appeal against the order passed in such proceedings.
(41)Art. 29 and 30, Law No. 55/2024 of 20/06/2024 on the Protection of Intellectual Property. The 2009 law had no provision for pre-grant challenge. This signifies Rwanda’s commitment to ensuring both the quality and validity of patents.The law reaffirms “distinctiveness” as a requirement for registration of trademark, while also clarifying that distinctiveness, in addition to inherent distinctiveness, should also mean distinctiveness acquired through continuous use.
(42)Art. 184, Law No. 55/2024 of 20/06/2024 on the Protection of Intellectual Property. This enhances trademark protection in Rwanda, which is critical to reduce consumer confusion, build loyalty and fight against counterfeiting, especially in cases involving health technologies.The law strengthens innovators’ rights by clarifying the “effect of publication” for patent application, utility model applications, industrial designs and trademark applications (Art. 28, Art. 87, Art. 114 and Art. 197).
(43)Art. 28, Art. 87, Art. 114 and Art. 197, Law No. 55/2024 of 20/06/2024 on the Protection of Intellectual Property. It grants applicants the same rights and privileges as if their IP were registered during the publication stage, unless a pre-grant opposition is filed. This further strengthens IP protection provided in Rwanda, making it easier for rights holders to protect and enforce their rights.
These changes demonstrate Rwanda’s commitment to advancing the goals of its 2018 IP policy, particularly in promoting scientific and technological innovations and their commercialization. They are expected to strengthen Rwanda’s IP ecosystem and create a more supportive environment for innovators.
Like the 2009 law, the 2024 law allows rights holders to pursue civil remedies for infringement and unfair competition by filing lawsuits.
May 2008 as part of the High Court of Rwanda, continues to handle IP cases. Its rulings can be appealed as per Rwandan law.
Criminal action in Rwanda addresses trademark and copyright infringements with penalties. Additionally, the IP law empowers customs authorities to suspend the clearance of counterfeit goods, a mechanism praised by IP law experts as both effective and popular. This multifaceted approach to IP enforcement demonstrates Rwanda’s commitment to safeguarding IP through diverse and robust strategies.
While the IP law experts interviewed for this study provided detailed accounts of the judicial and administrative remedies for IP matters in Rwanda, they noted there are no noteworthy examples of IP disputes or case laws in the MedTech sector, indicating minimal use of these remedies for MedTech.
Rwanda, as an ARIPO member, benefits from technical expertise and guidance, including support for IP registration, capacity building and regional collaboration on IP matters. WIPO’s statistics on IP filings in Rwanda (see Table 2) from 2023 show that RDB’s IP office is less burdened and has fewer filings, with the exception of trademark filings, compared to ARIPO.
Rwanda receives patent applications through its national IP office or ARIPO. Due to a lack of domestic technical expertise, Rwanda relies on ARIPO’s expertise for examination before granting patents.
In an interview with a leading Rwandan technology company, it was revealed that its leadership was unaware of ARIPO’s filing and designation system. The representative recommended raising awareness of regional filing systems in LDCs.
Feedback from IP experts from Rwanda highlighted a lack of technical capacity for drafting patent specifications and claims, and handling administrative steps for registration applicants and their agents. Although the processing time for a patent application can be as short as a year,
A review published by ARIPO showed that most of the patents filed for MedTech have either lapsed or been withdrawn.
Rwanda’s IP policy places a strong emphasis on advancing the health sector. Further, while there have been advancements in information and communication technologies that support healthcare services,
Feedback from stakeholder interviews highlighted the need for a deeper understanding of the MedTech ecosystem and the various forms of IP applicable to different products and their components.
Embracing innovation
Stakeholder feedback indicates that Rwanda’s proactive government attitude toward innovation and rapid policy reforms fosters an environment conducive to all types of innovations, including MedTech. The country’s policies attract foreign talent and facilitate the exchange of ideas, making it a regional hub for innovation. Centers of excellence and robust infrastructure, including widespread internet access and reliable electricity, further bolster Rwanda’s innovation capabilities.
Rwanda’s National Industrial Research and Development Agency (“NIRDA”) plays a significant role in supporting SMEs through various initiatives. These include assistance in product development and provision of training in several areas, particularly IP.
Filling the gaps
While Rwanda’s policy and legal framework for IP and innovation is promising, gaps remain between policy goals and on-the-ground practice, according to interviewees. Key areas for implementation include training and awareness programs across all facets of administration and enforcement; capacity building for IP experts; and a reassessment of fees to ensure they are not unintentionally discouraging filing. Stakeholders have highlighted WIPO’s role in training and teaching assistance in Rwanda and have recommended increased, continuous and consistent collaborations in the future.
Stakeholders interviewed for this study identified several areas for improvement to strengthen the IP and innovation ecosystem in the country. The key findings are summarized as follows:
Based on discussions with IP law practitioners in Rwanda, it has become apparent that the focus tends to be only on filing for and enforcing trademark rights, even within the MedTech industry. This trend indicates that innovators and entrepreneurs are investing neither time nor resources in developing a comprehensive IP portfolio that includes other forms of IPs, particularly patents. Furthermore, multinational MedTech companies and innovators often overlook Rwanda as a preferred jurisdiction for patent registration due to concerns about the functionality of its IP offices and enforcement mechanisms. In settings without robust IP enforcement, innovations may be vulnerable to infringement, which can deter companies from establishing operations in, or transferring technology to, these settings. It was the view of the IP practitioners who were interviewed that the full potential of IP in Rwanda remains untapped, and constraints via-à-vis technical capacity may hinder technology transfer and local manufacturing efforts.
Interviewees said that there is a general lack of IP awareness among all stakeholders in the country, including personnel in IP and regulatory offices, law enforcement agencies (who are often unaware of criminal provisions for IP enforcement), judges (who might struggle with understanding technical aspects of IP disputes), entrepreneurs and innovators. Consequently, a recurring recommendation that emerged from most of the interviews was to intensify IP training initiatives in Rwanda and maintain the collaborative efforts between WIPO and NIRDA in the following areas:
Judges presiding over general commercial courts handle civil IP cases, and there is room for enhancing their specialized technical expertise for healthcare-related filings.
There is a scarcity of patent attorneys in Rwanda, which results in a significant lack of technical expertise for patent drafting, filing, prosecution and litigation.
The IP filing and prosecution fees can be prohibitively expensive for individual applicants, startups and SMEs.
Awareness programs should start at the ground level. The lack of IP education in technical institutions highlights the need for schools to teach and equip students with theoretical knowledge of IP and practical skills.
IP policies should help to address certain health challenges. For example, the escalating challenge of counterfeit health technologies that can be purchased online necessitates the formulation of robust policies and legislation.
Regulatory systems
The country’s registering authority is the Rwanda Food and Drug Authority. The Rwanda FDA practices reliance, and foreign manufacturers can leverage their existing approvals in recognized markets (Australia, Canada, European Union countries, Japan and the United States) to receive expedited regulatory reviews and shorten their timelines.
Rwanda practices pharmaceutical regulatory harmonization through its membership in the East African Community Medicines Regulatory Harmonization Program;
In April 2020, the Regulations Governing Registration of Medical Devices including in vitro diagnostics came into effect. These regulations, which can be cited as Rwanda FDA regulations, include the registration procedures (see Box 9) applicable to all regulated human and veterinary medical devices, such as in vitro diagnostic dossiers submitted for market authorization.
On April 20, 2020, the Rwanda FDA adopted the provisions of the Regulations Governing Registration of Medical Devices.
The regulations were amended in 2021 to allow the regulatory authority to issue emergency use authorization when a national public health emergency has been declared or if the medical device meets certain requirements, such as being prequalified by WHO or previously registered or granted authorization for emergency use by countries that have collaborative agreements with Rwanda, among others.
In 2022, these guidelines were further revised to include in vitro diagnostics as products covered under this regulation.
To complement the technical regulations, Rwanda FDA has also issued Guidelines on Submission of Documentation for Registration of Medical Devices. The purpose of these guidelines is “to provide guidance to medical devices importers, manufacturers and distributors intending to market their products in Rwanda on the documentation requirements.”
Financial incentives
In 2018, the government launched the Rwanda Innovation Fund (RIF), which supports tech-enabled SMEs. This initiative is managed by the Rwanda National Council for Science and Technology and includes mentoring, incubation and funding. The council harnesses the RIF and mobilizes other top funders, like the Bill and Melinda Gates Foundation, to assist projects that address health-related needs. Interviewed stakeholders said that these initiatives supported multiple projects, which facilitated their progress toward commercialization. Projects supported by this initiative include the use of smartphone technology to self-manage NCDs like diabetes. See Box 10.
This case study explores a pioneering MedTech solution that leverages smartphone technology to empower patients in the self-management of diabetes. By providing accessible, cost-effective tools for daily health monitoring, the project aims to bridge healthcare gaps and improve the quality of life for patients, while laying the foundation for scalable digital health solutions in Rwanda.
The challenge
Type 2 diabetes is one of the most prevalent NCDs, accounting for over 90 percent of all cases of diabetes mellitus. It is linked to serious complications and other major NCDs, such as cardiovascular disease, hypertension, obesity and cancer. Once diagnosed, diabetes is a lifelong condition that significantly affects quality of life and requires costly long-term management.
The innovation and how it works
To address this challenge, the project leverages smartphone technology via a tele-genetics platform to help patients with type 2 diabetes self-manage their condition. The innovation consists of smartphone applications that support key self-management activities such as blood glucose monitoring, exercising, healthy eating, taking medications, and monitoring complications. The use of mobile health technology helps bridge gaps in primary care, especially where healthcare resources or patient access to care are limited. This approach requires minimal infrastructure and provides educational and motivational support to patients, reducing both health risks and costs.
Progress to date
Thus far, the project has received funding of 150 million Rwandan Francs (approximately USD 100,000), allowing the implementing team to deliver on key project activities. In addition to providing financial support, the National Council for Science and Technology has provided technical assistance, IP guidance and administrative support through monitoring and evaluation processes. The research team has engaged stakeholders, including the Rwanda Biomedical Center and the Ministry of Health, to explore the integration of the platform into the national healthcare system. Initial pilot tests with type 2 diabetes patients have yielded positive feedback, with users reporting improvements in their health since adopting the system.
IP strategy
The research team secured copyright protection for the system’s software through the RDB and registered a trademark for the associated online clinic. Looking ahead, they plan to formally register the clinic to establish its legal standing and expand access to digital diabetes management services. This IP strategy not only safeguards the technology but also lays the groundwork for future commercialization.
Lessons learned: enablers and challenges
The project benefited financially and technically from strong government support through the National Council for Science and Technology, which provided crucial guidance on IP registration and monitoring and evaluation processes. These enablers helped the team innovate and gain initial traction. However, the team faced significant challenges related to IP ownership. There was a lack of clarity from the outset regarding IP rights, as expectations from university and industry partners differed. These differences created complications over who would retain the IP, highlighting the need for clearer agreements when academic institutions and private sector partners collaborate on projects.
A major lesson learned is the importance of establishing clear IP ownership and collaboration frameworks from the beginning, especially when working with multiple stakeholders. This ensures smoother innovation processes and commercialization. Moreover, strengthening policies that foster collaboration between research institutions and the private sector is essential for sustainable innovation.
Source: Jean Pierre Hakizimana, National Consultant
In August 2020, the Rwanda Ministry of ICT (Information and Communications Technology) & Innovation held the first of three meetings to discuss the development of Rwanda’s Startup Act intended to build a stronger entrepreneurial ecosystem.
As shared by stakeholders during interviews, the private sector, driven largely by external funding, plays a pivotal role in Rwanda’s innovation landscape. The government of Rwanda is a major buyer of healthcare technologies and, as such, a balance between market-driven solutions and public sector support remains critical.
Local MedTech industry capacity
Rwanda is the host of the regional Center of Excellence in eHealth and Biomedical Engineering and the African Medicines Agency, i.e., Africa’s medical regulatory body. In the past two decades, Rwanda has added several educational programs aimed at increasing the capacity of the country to innovate in the medical sector. For example, in 2010, Rwanda added a biomedical engineering curriculum to the Integrated Polytechnic Regional Center.
The Kigali-based East Africa Biodesign Program is a 10-month fellowship program focused on biomedical innovation on the continent. It is a collaboration among the University of Global Health Equity (UGHE), the University of Rwanda, Kenyatta University and the Stanford Byers Center for Biodesign.
The local production of MedTech in LDCs is a complex opportunity. Governments can support the innovation ecosystem to nurture local product development. As knowledge producers, academic institutions play a fundamental role in the development of local innovation ecosystems.
The Stanford Biodesign Fellowship Program was launched in 2000 offering medical technology postgraduate training to physicians and engineers wishing to translate clinical insights into new technologies.
Since its inception, the program’s curriculum has followed a three-phase process: identification, invention and implementation.
Over the course of the 12-month program, fellows can leverage the expertise of local MedTech experts, venture capitalists, regulatory experts, coaches and mentors who guide them at every stage of the biodesign process.
During the first five years of the program, over 200 fellows and graduate students were trained and nine companies were formed based on products developed by the fellows. The success of the program prompted Stanford officials to consider broadening the project’s scope to train leaders from around the world in biomedical technology innovation. They set up local biodesign programs in several countries, including India, Ireland, Japan and Singapore. Adapting lessons learned from these centers, the Stanford Biodesign Program was recently launched in Rwanda.
East Africa Biodesign is a global collaboration among the UGHE, the University of Rwanda, Kenyatta University and Stanford Biodesign. The program aims to enhance health outcomes and equity for underserved populations in East Africa by training local innovators to develop appropriate, accessible and sustainable health innovations.
Rwanda can leverage the lessons from other countries to build up its MedTech innovation ecosystem with the technical support of the Biodesign Program. For example, political leadership and local champions are important to build up local institutional capacity. In India, the biotechnology secretary championed the Biodesign Program and provided necessary infrastructure and support, such as research laboratories and hospital immersions. This was accompanied by identifying technical experts and institutions to oversee the program’s operations. The Indian Institutes of Technology housed the program with an engineering faculty to provide expertise and guidance to the students. Simultaneously, a leading cardiologist from the government provided medical expertise and access to hospitals to support clinical immersions.
Based on the existing Biodesign Program, a new curriculum was developed, and the Stanford-India Biodesign Program was launched with the goal of training Indian MedTech innovators who would support the country’s then-nascent MedTech industry to address local needs.
Programming biodesign to meet each country’s needs
The Stanford Biodesign Program is adaptable to each country’s unique needs. For example, India offered a slightly different approach than the one offered in the original Stanford Biodesign Program. For starters, it was designed to be a two-year, team-based fellowship instead of a one-year program. There are 11 affiliated biodesign centers across India today that provide end-to-end support to help students identify clinical needs, develop and test their prototype solutions and take their products to market. This includes incubation support, IP protection, valuation and commercialization. As a result of the program, a number of innovators have filed for patents.
The Biodesign Program also forges strong partnerships among universities, innovators and industry to facilitate the commercialization process. In India, a number of partnerships were established for product development, licensing and technology transfer to scale up local manufacturing and distribution of MedTech.
The biodesign process is transferable and applicable to LDCs in Africa, Asia and Latin America. But this requires investing in the development of well-trained engineers and clinicians to support local R&D efforts. Several leading universities across the continent are developing strong medical and engineering faculties to lead the way. Strong partnerships between local and global universities can help to build up local research and development capabilities in the MedTech sector. This will take time to develop, and once it does, it will be important to retain that operational experience and expertise in the country.
The program’s multidisciplinary approach, focus on local needs and hands-on training, coupled with the strong mentorship and networking opportunities for the fellows, have made these programs sustainable, scalable and impactful.
East Africa, in general, has found academic partnerships with training institutions in Africa and in the global north to be great for developing human resources and building capacity, finding that “70% of science and technology publications from East Africa – and probably a greater proportion for MedTech – involve international collaborations.”
Feedback from stakeholders highlights good practices in academic programs to support innovations in Rwanda, for example:
Universities engage in research on how to implement innovations, i.e., investigating whether published research translates into practical applications on the ground.
In many cases, universities have their own IP policies (which typically include guidance on licensing and technology transfer) and provide assistance to innovators to file their IP.
There is increased support from the government for innovation projects
However, feedback also highlights certain challenges. For example:
Limited resources and prototyping spaces (dedicated spaces equipped with relevant tools and resources to facilitate creation and testing of prototypes)in Rwanda necessitate collaborations with other countries such as India and China, complicating back-and-forth logistics. The country faces deficiencies in manufacturing capacities and resources for conducting clinical trials, which are crucial for healthcare technologies.
There is a need not only to train doctors and biomedical engineers, but also to educate and employ health professionals, such as technicians and pathologists.
There are limited opportunities to foster meaningful collaboration among multidisciplinary teams, including medical professionals, scientists, technologists and engineers.
Most stakeholders praised Rwanda’s private and public sector actors for enhancing essential infrastructure, including electricity, roads and internet. Additionally, they acknowledged the expansion of healthcare access through investments in related sectors like drone technology and digital payment applications, such as Flutterwave,