The World Health Organization (WHO) has announced a significant expansion of its prequalification programme to include a broader range of life-saving medical devices. This move aims to increase access to quality-assured, safe, and effective products, particularly in countries with limited regulatory capacity. The programme already covers in vitro diagnostics and male circumcision devices. WHO's prequalification programme ensures that essential health products meet international quality, safety, and performance standards for global procurement.
The expansion is crucial for countries with inadequate or weak regulatory systems for medicines and vaccines. According to WHO, an estimated 70% of countries report such challenges, which are even more pronounced for other health products. By broadening the programme, WHO will help countries improve access to quality-assured medical devices, including male and female condoms, intrauterine devices (IUDs), and computer-aided detection software for tuberculosis (CAD-TB) screening.
Dr. Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, emphasized the importance of the expansion. She stated that everyone should be able to rely on medical devices that are safe, effective, and meet high standards of quality. The expansion of WHO prequalification will strengthen confidence in these essential health products and help countries expand equitable access to the technologies people need to protect and improve their health.
A key part of the expansion involves 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, as 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.
The expansion also includes male circumcision devices, which are now part of WHO's broader medical device prequalification framework. Previously, these devices were 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%.
Additionally, the expansion 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 high TB rates, where reliable screening can help detect TB earlier and connect people to diagnosis and treatment quickly.
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.
Key points
- WHO expands prequalification programme to include contraceptives and TB screening technologies
- Expansion aims to increase access to quality-assured medical devices in countries with limited regulatory capacity
- Programme ensures essential health products meet international quality, safety, and performance standards for global procurement
