WHO Expands Quality Checks for Contraceptives and AI Tools That Help Spot Tuberculosis

WHO prequalification assesses essential health products against international standards for quality, safety and performance through an independent, standardized and transparent process.

People relying on contraceptives or seeking screening for tuberculosis need confidence that the products used in their care meet reliable standards, a concern behind the World Health Organization's expansion of its medical device prequalification programme. WHO is broadening the programme to cover more essential products, including male and female condoms, intrauterine devices (IUDs) and artificial intelligence software that helps identify possible TB cases. The expansion builds on a programme that already covers in vitro diagnostics, or medical tests, and male circumcision devices, giving countries a wider range of independently assessed products to guide purchasing decisions.

Stronger quality checks where countries need support

WHO prequalification assesses essential health products against international standards for quality, safety and performance through an independent, standardized and transparent process. Medical devices that meet the requirements are added to WHO's list of prequalified products, which provides trusted guidance for United Nations agencies, procurement organizations, donors and national authorities. For organizations buying supplies for health services, this assessment offers a shared reference when choosing products that people depend on for prevention, screening and care.

The expansion carries particular importance for countries with limited capacity to regulate health products, where checking the quality of available devices can be difficult. An estimated 70% of countries report inadequate or weak regulatory systems for medicines and vaccines, with even greater challenges affecting other health products. Dr Sylvie Briand, WHO Chief Scientist and acting Assistant Director-General for Health Systems, Access and Data, said the broader programme would strengthen confidence in essential medical devices and help countries improve equitable access to technologies people need to protect their health.

Contraceptives move into WHO's broader framework

Prequalification for male and female condoms and IUDs is moving from the United Nations Population Fund (UNFPA) to WHO, bringing these contraceptives into the expanded programme. Access to quality-assured products supports sexual and reproductive health by helping people prevent unintended pregnancies and make informed family-planning decisions. Condoms have an additional role in protecting against HIV and other sexually transmitted infections, making dependable product quality relevant to several aspects of a person's health.

Male circumcision devices, which WHO previously assessed through a separate process, are becoming part of its broader medical device prequalification framework. Prequalified devices support safe, standardized voluntary medical male circumcision services, an intervention that can reduce men's risk of acquiring HIV through heterosexual exposure by approximately 60%. Their inclusion brings an existing area of WHO assessment into the wider framework covering essential medical devices.

AI screening tools offer support for earlier TB detection

Computer-aided detection software for tuberculosis, known as CAD-TB, brings a digital health technology into WHO's prequalification programme. The software uses artificial intelligence to analyse digital chest X-rays and identify people who may have TB and need further testing, supporting the screening stage of care rather than providing a confirmed diagnosis. Its inclusion extends quality assessment to technology that can help health services identify people who need closer examination.

Reliable screening is especially important in countries with high TB rates, where identifying possible cases earlier can help people reach diagnostic services and treatment more quickly. The expanded programme gives countries and purchasing organizations a trusted basis for selecting these tools, extending the same emphasis on quality, safety and performance to digital screening technologies and established medical devices. WHO's announcement places confidence in the products used in everyday health services at the centre of its effort to improve access.