The World Health Organization (WHO) has expanded its prequalification programme to include a wider range of life-saving medical devices, including contraceptives and innovative tuberculosis (TB) screening technologies.
The programme helps ensure that essential health products meet international standards for quality, safety and performance. Through an independent and transparent assessment process, WHO evaluates medical devices before listing products that meet the required standards for use by United Nations agencies, procurement organisations, donors and national authorities.
The expansion will support countries with limited regulatory capacity by improving access to quality-assured medical devices, including male and female condoms, intrauterine devices (IUDs), computer-aided detection (CAD) software for TB screening and male circumcision devices.
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As part of the expansion, responsibility for prequalifying male and female condoms and IUDs is transferring from the United Nations Population Fund (UNFPA) to WHO. These products are important for sexual and reproductive health, including family planning, prevention of unintended pregnancies, HIV and sexually transmitted infections.
“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.”
The programme will also assess CAD software for TB screening. These digital tools use chest X-rays and artificial intelligence to identify people who may have TB and require further testing, potentially supporting earlier detection and access to treatment.
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