WHO Expanded Medical Device Prequalification List
The program now includes contraceptives and new AI-driven tools for tuberculosis detection.
Updated on Sept. 30, 2026 in Sexual Health
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The World Health Organization has expanded its medical device prequalification program to include contraceptives and AI-driven tuberculosis screening software. This initiative aims to assist nations in identifying and procuring safe, effective health technologies.
Why it matters
The move addresses a critical gap in global health infrastructure, as roughly 70% of countries currently report weak regulatory systems for health products. By standardizing the assessment process, the WHO provides essential guidance for nations to secure quality equipment.
A significant 70% of countries report inadequate health product regulatory systems. Additionally, voluntary medical male circumcision, a previously assessed technology, reduces HIV acquisition risk by approximately 60%.
The players
World Health Organization
This is a specialized agency of the United Nations responsible for international public health.
United Nations Population Fund
This is the United Nations sexual and reproductive health agency that previously managed prequalification responsibilities for condoms and IUDs.
The details
The program now encompasses male and female condoms, intrauterine devices, and computer-aided detection software that uses AI algorithms to analyze digital chest X-rays for tuberculosis. Products must pass a standardized and transparent independent assessment process before being added to the official WHO list.
Timeline
September 30, 2026: The WHO announced the expansion of the prequalification program.
The Big Picture
The expansion follows a pattern set by the WHO global health product prequalification framework by broadening the scope of validated technologies available to member states.
The expansion will help standardize the quality and safety of essential medical devices available in local healthcare facilities. Patients should have increased access to reliable diagnostic tools and reproductive health products as more manufacturers complete the assessment process.
The takeaway
This expansion streamlines the procurement of essential health technologies for resource-limited nations. Patients and providers can prioritize these prequalified devices to ensure better diagnostic accuracy and reproductive safety.
Further reading
For more information on global health initiatives, visit the Sexual Health section.
Source note: This article includes information reported by MDDI Online.
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