WHO expands quality assessment of medical devices

WHO is expanding its prequalification programme for medical devices, broadening a system used to support quality-assured health procurement.

The expanded scope includes contraceptive products and computer-assisted analysis of digital chest X-rays for tuberculosis screening. Some contraceptive prequalification responsibilities are being transferred from UNFPA.

The programme assesses quality, safety and performance to help procurement agencies and health systems evaluate products, particularly where regulatory resources are limited. AI-assisted chest X-ray analysis is a screening aid within a diagnostic pathway; it should not be confused with a stand-alone confirmation that a person has tuberculosis.