KENYA—Revital Healthcare EPZ of Kenya, East Africa’s largest manufacturer of auto-disabled syringes, has been granted World Health Organization (WHO) Prequalification for its auto-disabled (AD) products.

WHO prequalification aims to enable access to vital health goods that meet global quality, safety, efficacy, or performance criteria, resulting in more efficient use of health resources and improved health outcomes.

WHO prequalification has become a widely accepted and reputable emblem of safety, quality, and efficacy among stakeholders.

Products that successfully meet WHO vaccination product and device requirements are termed “prequalified” for use in any applicable country’s immunization program.

UN agencies recommend the purchase of only devices recognized in the WHO Catalogue of Prequalified Immunization Devices.

Approximately 1,500 products have been prequalified to date, including in vitro diagnostics (IVDs), male circumcision devices, medicines, vaccines, immunization devices, cold chain equipment, and vector control products, to help improve public health in low- and middle-income countries (LMIC).

These AD syringes, designed for use in bulk immunization programs, are locked after one use to prevent reuse, increasing the safety of vaccines and minimizing the risk of infections caused by infected needles.

Revital Healthcare’s achievements in WHO prequalification are consistent with Africa CDC’s strategic goal of expanding local manufacturing and innovation of health products on the continent, making it the first company in East and Central Africa to produce medical devices.

As Africa’s leading medical equipment maker, exporting to more than 30 countries worldwide, the company also manufactures more than 50 different medical devices.

Furthermore, it has played a crucial role in Africa’s COVID-19 response, demonstrating African manufacturers’ ability to provide critical medical supplies to the continent. 

The establishment of key continental agencies and coordination bodies, such as the Partnership for African Vaccine Manufacturing, African Medicines Agency, African Medical Supplies Platform, and the Africa Pharmaceutical Technology Foundation, has significantly advanced the agenda for local manufacturing.

The Partnerships for African Vaccine Manufacturing, which was founded to boost the African vaccine manufacturing ecosystem, intends to have Africa produce 60% of the continent’s vaccines by 2040.

However, achieving the vision of a self-sufficient Africa necessitates concerted efforts to ensure that no country falls behind. Effective coordination between these entities is required for formulating integrated and consistent regulatory policies for developing sustainable markets across Africa.

 A transformative shift can be realized by action-oriented collaborations and collaborative efforts by all stakeholders, in which African producers meet the continent’s health commodities demands while governments actively contribute to these goals.

 By encouraging the expansion of local manufacturing, Africa is paving the path for strong and self-sufficient health systems, guaranteeing that people can get and use health commodities when and where they need them.

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