WHO expands medical-device prequalification

WHO announced on September 25 that medical-device prequalification now covers male and female condoms, intrauterine devices, computer-aided detection software for tuberculosis screening and male-circumcision devices. CAD-TB uses digital chest X-rays and AI to flag people who may need further testing. Products that pass an independent, standardized and transparent assessment enter the WHO list used by UN agencies, procurers, donors and national authorities. WHO says about 70% of countries report inadequate or weak systems for medicines and vaccines, with larger gaps for other health products. Prequalification improves procurement confidence but does not replace national registration, training or post-market surveillance.