Published event date: 25 September 2026. Last reviewed: 26 September 2026.
- WHO has expanded its prequalification programme to additional medical devices.
- Eligible areas now include male and female condoms, intrauterine devices, computer-aided detection software for TB screening and male circumcision devices.
- Prequalification supports procurement decisions; it is not the same as approval in every country.
The World Health Organization announced on 25 September 2026 that its prequalification programme will cover a wider range of medical devices. The change is intended to give UN agencies, procurement organisations, donors and national authorities an independently assessed list of products meeting specified quality, safety and performance requirements.
What is new?
Contraceptive devices previously assessed through UNFPA—including male and female condoms and IUDs—are moving into the WHO framework. Computer-aided detection software that analyses digital chest X-rays to identify people who may need confirmatory tuberculosis testing is also included. Male circumcision devices are being incorporated into the broader programme.
Why it matters
WHO says many countries have limited regulatory capacity. A transparent assessment pathway can help procurement teams compare eligible products and may improve access to quality-assured reproductive-health and TB-screening technologies.
What doctors and patients should understand
CAD-TB software is a screening aid, not a stand-alone diagnosis. A positive screen still requires the diagnostic pathway recommended by national TB programmes. Similarly, inclusion of a contraceptive device in a WHO list does not replace clinical eligibility assessment, counselling, informed choice or local registration requirements.
Verified facts and limitations
The announcement defines the programme’s expanded scope, but it does not say that every product in these categories is already prequalified. Manufacturers must apply and complete the applicable assessment. Product availability, regulatory status and procurement in India must be checked through CDSCO, national programmes and local policy.
Official sources
Featured image credit: Trnava University/Unsplash (licensed stock image; illustrative).
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