WHO Announces Expansion of Prequalification Programme for Medical Devices

25 September 2026

World Health Organization news release

The World Health Organization (WHO) announced a major expansion of its prequalification programme to include a wider range of life-saving medical devices such as contraceptives and innovative 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.

Regarding TB, the expansion includes computer-aided detection (CAD) software for 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.

More information on the transition, next steps and the first assessment wave for contraceptive devices, CAD-TB products and male circumcision devices is available on the WHO website.

Read the full news release here.

Source: World Health Organization