WHO expands prequalification programme to condoms, intrauterine devices and TB detection software

25 September 2026

WHO announced on 25 September 2026 that it is expanding its prequalification programme beyond in vitro diagnostics to cover more medical devices.
The categories added are male and female condoms, intrauterine devices, computer-aided detection (CAD) software for tuberculosis screening, and male circumcision devices.
Responsibility for prequalifying condoms and intrauterine devices moves from the UN Population Fund to WHO.
An estimated 70 per cent of countries report inadequate or weak regulatory systems for medicines and vaccines, with even greater gaps for other health products.
CAD software uses digital chest X-rays and artificial intelligence to flag possible tuberculosis cases for confirmatory testing.
WHO says voluntary medical male circumcision can reduce a man's risk of acquiring HIV through heterosexual exposure by about 60 per cent.
WHO Chief Scientist Sylvie Briand said everyone everywhere should be able to rely on medical devices that are safe, effective and meet high standards of quality.