The World Health Organization (WHO) today announced a major expansion of its prequalification programme to include a wider range of life-saving medical devices such as contraceptives and innovative tuberculosis (TB) screening technologies. This broadens the range of quality-assured, safe and effective products covered by the programme, which already includes in vitro diagnostics (medical tests) and male circumcision devices.
The WHO prequalification programme helps ensure that essential health products meet international quality, safety and performance standards for global procurement. Medical devices are assessed through an independent, standardized and transparent process. Products that meet the required standards are included in the WHO list of prequalified medical devices, providing trusted guidance for United Nations agencies, procurement organizations, donors and national authorities.
The expansion is particularly significant for countries with limited regulatory capacity. An estimated 70% of countries report inadequate or weak regulatory systems for medicines and vaccines, with even greater challenges for other health products. By expanding the programme, WHO will help countries improve access to quality-assured medical devices such as male and female condoms, intrauterine devices (IUDs), computer-aided detection software for tuberculosis (CAD-TB) screening and male circumcision devices.
"Everyone, everywhere, should be able to rely on medical devices that are safe, effective and meet high standards of quality," said Dr Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data. "By expanding WHO prequalification, we are strengthening confidence in these essential health products and helping countries expand equitable access to the technologies people need to protect and improve their health."
More quality-assured products for sexual and reproductive health, TB screening
A key part of the expansion is the transfer of prequalification for male and female condoms and IUDs from the United Nations Population Fund (UNFPA) to WHO. Access to quality-assured condoms and IUDs is essential for sexual and reproductive health. These products help prevent unintended pregnancies and support informed decisions about family planning. Condoms also play a critical role in preventing HIV and other sexually transmitted infections.
Male circumcision devices are now part of the WHO's broader medical device prequalification framework, whereas they were previously assessed under a separate process. WHO prequalified devices support safe, standardized voluntary medical male circumcision services, which can reduce men's risk of acquiring HIV through heterosexual exposure by approximately 60%.
The expansion also includes computer-aided detection (CAD) software for tuberculosis (TB) screening, bringing a digital health technology into the WHO prequalification programme. CAD software uses digital chest X-rays and artificial intelligence to identify people who may have TB and need further testing. This is particularly important in countries with a high TB rate, where reliable screening can help detect TB earlier and connect people to diagnosis and treatment quickly.
