The World Health Organization (WHO) announced, on Friday, September 25, the extension of its prequalification program to a new range of medical devices deemed essential. Male and female contraceptives, intrauterine devices (IUDs), artificial intelligence-based tuberculosis screening tools, and voluntary medical male circumcision instruments: these are the categories now subject to the UN agency’s evaluation framework. While the announcement may seem technical, it touches on considerable public health issues, particularly for African countries whose regulatory systems remain fragile.
A prequalification program — what for?
WHO prequalification is, in practice, an independent quality assurance mechanism. It subjects medical products to rigorous evaluation before listing them on an official register. This list then serves as a reference for UN agencies, international procurement funds, donors and national governments when making purchases. In other words, appearing — or not — on this list determines manufacturers’ access to public health markets worldwide.
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For countries whose regulatory authorities lack human and technical resources, this label often represents the only available filter for distinguishing a reliable product from a defective or counterfeit one. The WHO itself acknowledges this in its press release: according to the organization, “nearly 70% of countries report insufficient regulatory systems for medicines and vaccines, while difficulties are even greater regarding medical devices.” This assessment applies to a large majority of African states, where national medicines agencies exist but have limited resources to examine complex technical dossiers.
Contraceptives and IUDs: a transfer of competencies from UNFPA
One of the notable institutional changes of this extension concerns male and female condoms as well as intrauterine devices. Their prequalification, previously handled by the United Nations Population Fund (UNFPA), is being transferred to the WHO. This shift of responsibility within the UN system deserves attention: it further centralizes quality assessment under the umbrella of a single agency, which may simplify procedures for buyers, but raises the question of the WHO’s capacity to absorb this additional workload without lengthening evaluation timelines.
The organization emphasizes the health importance of this component: quality-certified contraceptives contribute, according to it, to preventing unwanted pregnancies, supporting family planning and reducing the transmission of HIV and other sexually transmitted infections. In sub-Saharan Africa, where rates of unintended fertility and HIV prevalence remain concerning in certain regions, access to reliable products remains a structural challenge as much as a public health priority.
Medical circumcision and tuberculosis: two fronts against persistent epidemics
The inclusion of voluntary medical male circumcision devices in the prequalification program responds to a documented epidemiological rationale. The WHO notes in its press release that “voluntary medical male circumcision can reduce the risk of HIV infection during heterosexual intercourse in men by approximately 60%.” In several countries in southern and eastern Africa where national circumcision programs have been deployed at scale, the quality of the devices used directly determines the safety of the procedures. Prequalification of these tools aims to standardize their reliability.
The digital component of the extension is perhaps the most innovative. The WHO is now integrating into its framework computer-aided detection software for tuberculosis (CAD-TB). These tools rely on the analysis of digital chest X-rays by artificial intelligence algorithms to identify suspected cases and quickly direct patients toward a confirmed diagnosis. In countries with high tuberculosis prevalence — including several in West and East Africa — these solutions could theoretically accelerate screening where qualified radiologists are scarce. However, their actual effectiveness depends on infrastructure conditions (imaging equipment, connectivity) that the WHO press release does not address.
What the announcement does not say
While the broadening of the prequalification program represents a real step forward on a normative level, several questions remain unanswered in the elements communicated by the WHO. First, that of the operational timeline: when will the first effective prequalifications in these new categories be issued? Which manufacturers — particularly African ones — are in a position to apply, and at what cost? WHO prequalification involves lengthy and costly procedures, which can de facto exclude emerging local producers in favor of established industry players.
Then, the question of translation on the ground: a prequalification granted in Geneva does not automatically guarantee the accessibility of a product in a rural health post in the Sahel or in a peri-urban clinic in Central Africa. Supply chains, health financing, national procurement policies and logistical capacities remain links that are independent of this framework.
Finally, the integration of artificial intelligence tools into a UN regulatory framework raises questions of algorithmic governance that are still widely debated in the scientific community: what clinical validation in specific African contexts, what updating of algorithms, what accountability in the event of a detection error?
Putting it in perspective
The extension of the WHO prequalification program is part of a broader movement to strengthen international standards for medical devices, a sector historically less regulated than that of medicines. For Africa, where a substantial share of health systems still depends on the financing and purchasing decisions of international actors, this normative development can have concrete effects — provided that states incorporate these reference lists into their national procurement policies and that local manufacturers are supported in accessing the process. It is these dynamics of ownership, beyond the institutional announcement, that will need to be monitored in the coming months.
Frequently asked questions
What is the WHO prequalification program?
It is an independent evaluation mechanism established by the World Health Organization to certify that medicines, vaccines or medical devices meet international standards of quality, safety and performance. Prequalified products are listed on an official register used by UN agencies, donors and governments as a reference for their purchases.
Why is this extension particularly important for African countries?
The WHO estimates that nearly 70% of countries have insufficient regulatory capacity to evaluate medicines and medical devices. This situation affects many African states, for which WHO prequalification often constitutes the primary quality filter available during public health procurement.
What are the new devices covered by this expanded program?
According to the WHO press release, the extension includes male and female condoms, intrauterine devices (whose prequalification is transferred from UNFPA), voluntary medical male circumcision instruments, and computer-aided detection software for tuberculosis (CAD-TB) using artificial intelligence.
Can African manufacturers access WHO prequalification?
Technically, the program is open to any manufacturer, regardless of origin. However, prequalification procedures are known to be lengthy and require significant technical and financial resources, which can represent an obstacle for local industry players still in development. This question of accessibility to the process remains an issue unaddressed in the organization’s announcement.
