Kenya - Country Commercial Guide
Healthcare - Medical Devices
Last published date:

Nearly 70% of Kenya’s healthcare services are provided by the public sector, through the Ministry of Health (MoH) and other government-funded bodies. Healthcare services are supplemented by hospitals and clinics run by private companies, NGOs, and faith-based organizations. Emergency ambulance services and disaster relief management are provided by the Kenyan Red Cross. National healthcare funding is heavily supported by bilateral and multilateral donor partners, including the United States through the U.S. Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC).

For example, USAID supports Kenya’s health sector with high-impact, evidence-based interventions with most interventions implemented at the county level due to funding challenges. Support provided through partnership with counties, local institutions, faith-based organizations, and the private sector is on prevention and treatment of HIV, Malaria, Tuberculosis (TB) and on reproductive, maternal, newborn, child, and adolescent health, nutrition, water, sanitation, and hygiene.

The high cost of healthcare remains a major barrier to access, especially for the poor who spend a large share of their household income to meet their healthcare needs. The government’s Universal Healthcare Coverage (UHC) program prioritizes broadening access to services, strengthening primary healthcare, increasing medical staff and medical supplies, digitizing health operations, and scaling up the National Health Insurance Fund (NHIF), with recent amendments to the law leading to the establishment of the Social Health Insurance Fund (SHIF). Heavy investments in private hospitals coupled with availability of skilled medical professionals has put the country as a leading medical tourism destination in East Africa.

The MoH is the lead healthcare policy-setting government institution in Kenya. The Pharmacy and Poisons Board (PPB), an agency under the Department of Medical Services at the MoH, is the regulatory body for registration of medical devices.

Kenya incorporated all medical devices, food supplements, medical cosmetics, herbal products, and other allied borderline healthcare products into the pre-export verification of conformity (PVoC) program. The Kenya Bureau of Standards (KEBS) and PPB determines the import requirements for these products to protect the public against products that do not comply with local quality standards and technical regulations. A certificate of conformity (CoC) for customs clearance at the border is required by importers of these products before applying for import license permits from the PPB.   

Public procurement for both medical equipment and pharmaceuticals is done by the Kenya Medical Supplies Agency (KEMSA), a state-owned corporation and a specialized medical logistics provider for the MoH. Centralized purchasing and procurement are often used in both public and private hospitals to obtain economies of scale. All public tenders are advertised on the KEMSA website and must adhere to the Public Procurement Act. The country is a promising market for medical equipment and has been ranked as one of the fastest growing markets in the sub-Saharan Africa region according to the Business Monitor International (BMI). The medical device sector relies heavily on imports with very little domestic production taking place due to limited manufacturing infrastructure, weak technical capacity, and lack of access to raw materials. The U.S. market share for medical devices sales in Kenya was estimated at 6.5% at the end 2022, and ranked sixth after China, India, France, Germany, and the Netherlands. 

For medical device exports in 2022, consumables and orthopedics were the largest product areas, responsible for around 37.2% and 35.3% of total exports, respectively. This was followed closely by other medical devices, which accounted for 21.3% of total exports. Dental products, diagnostic imaging, and patient aids accounted for the remainder of total U.S. exports to Kenya, in that order.

Opportunities

Diagnostic Imaging Equipment: 

Best prospects for diagnostic equipment include electrocardiographs (ECG); ultrasound units; scintigraph apparatus; MRI equipment; angiographies; endoscopies; and biochemistry, hematology, and immunology systems. Hospital groups also seek radiation equipment including radiotherapy machines, CT scanners, X-ray machines, and imaging parts and accessories such as contrast media, medical x-ray films, x-ray tubes, and other parts and accessories.

Dental Equipment:

Best prospects for dental equipment include dental drills; chairs; and X-ray equipment, instruments, supplies such as dental cement, teeth and other fittings, and artificial teeth.

Orthopedics and Prosthetics: 

Best prospects include fixation devices, artificial joints, and other artificial body parts.

Patient Aids: 

Best prospects include hearing aids, pacemakers, and therapeutic appliances, such as therapeutic respiration and mechano-therapy apparatus.

Lab Equipment/Reagents: 

The need for self-testing kits is growing steadily as the government approves licensing for rapid diagnostic tests (RDT) for malaria, HIV, and COVID-19.

Consumables: 

Local production of basic consumables remains low, providing opportunities for U.S. companies. Best prospects include bandages and dressings, suturing materials, catheters, syringes, surgical gloves, and blood grouping reagents.

Others:  

Other prospects include hospital furniture, anesthetic machines, anesthetic trolleys, hydraulic operating tables, delivery beds, infant incubators, mortuary trolleys, hydraulic operating tables, mercurial sphygmomanometers, and oxygen flow meters.

Pharmaceuticals

The pharmaceutical industry in Kenya offers excellent opportunities for U.S. companies to promote their products and services, whether through direct manufacturing or indirectly through local distribution channels. Kenya is currently the largest producer of pharmaceutical products in the COMESA region, supplying about 50% of the regions market. The attractiveness of Kenya’s pharmaceutical market to innovative drug makers is hampered by low income levels and an underdeveloped healthcare sector characterized by lack of infrastructure and structured sales channels.

A good resource for analyzing pharmaceutical needs is the Kenya Essential Medicines List (KEML), derived from the WHO Model List 23rd edition (adults) of 2023 and 9th edition (children) of 2023.

Resources

Kenya Medical Devices Report (Fitch Solutions)

Kenya National Bureau of Statistics

Ministry of Health

World Health Organization

 

Major Shows

Medic and Medlab East Africa 2023

Africa Health 2023

Arab Health 2024 (Dubai)

 

For more information, the U.S. Commercial Service in Nairobi, Kenya, can be contacted via e-mail at:

Janet Mwangi

Senior Commercial Specialist
U.S. Commercial Service, U.S. Embassy Nairobi
U.S. Department of Commerce | International Trade Administration

Tel: +254 20 363 6724 Janet.Mwangi@trade.gov