By Ayomide Otitoju
The World Health Organization (WHO) has expanded its prequalification programme to cover a wider range of life-saving medical devices, including contraceptives and innovative tuberculosis (TB) screening technologies.
The expansion broadens the range of quality-assured, safe and effective products covered by the programme, which already includes in vitro diagnostics and male circumcision devices.
The WHO prequalification programme assesses essential health products against international quality, safety and performance standards through an independent, standardised and transparent process.
Products that meet the required standards are included on the WHO list of prequalified medical devices, providing guidance for United Nations agencies, procurement organisations, donors and national health authorities.
WHO said the expansion would be particularly important for countries with limited regulatory capacity. An estimated 70% of countries report inadequate or weak regulatory systems for medicines and vaccines, with greater challenges affecting other health products.
The expanded programme will cover products including male and female condoms, intrauterine devices (IUDs), computer-aided detection (CAD) software for 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.
She said the expansion would strengthen confidence in essential health products and help countries improve equitable access to technologies needed to protect and improve health.
As part of the expansion, responsibility for prequalifying male and female condoms and IUDs will transfer from the United Nations Population Fund (UNFPA) to WHO.
WHO said access to quality-assured condoms and IUDs is essential to sexual and reproductive health, helping prevent unintended pregnancies and supporting family planning decisions. Condoms also help prevent HIV and other sexually transmitted infections.
Male circumcision devices have also been incorporated into WHO’s broader medical device prequalification framework after previously being assessed under a separate process.
WHO said prequalified devices support safe and standardised voluntary medical male circumcision services, which can reduce men’s risk of acquiring HIV through heterosexual exposure by about 60%.
The programme will also include CAD software for TB screening, bringing digital health technology into the prequalification framework.
The software uses digital chest X-rays and artificial intelligence to identify people who may have TB and require further testing.
WHO said the technology could be particularly useful in high-TB-burden countries by supporting earlier detection and faster links to diagnosis and treatment.
