Prequalification of Medical Devices | WHO

The World Health Organization (WHO) has significantly broadened its scope for medical device prequalification, a move designed to standardize the quality and reliability of critical health tools on a global scale. Since 2011–2012, the organization has focused its prequalification efforts on male circumcision devices (MCDs) to support HIV prevention in regions with high incidence and low prevalence rates. This year, the program has expanded to include a wider array of essential reproductive and diagnostic technologies.

Expanding the Scope of Global Health Standards

In 2026, the WHO extended its assessment framework to include computer-aided detection (CAD) software for tuberculosis screening, as well as male latex condoms, female condoms and copper-bearing intrauterine devices (Cu-IUDs). By centralizing the assessment of these reproductive health products—which were previously coordinated with the United Nations Population Fund (UNFPA)—the WHO is streamlining the oversight process within its dedicated Prequalification Unit.

The inclusion of CAD-TB software marks a technological shift in how the WHO addresses infectious disease. These devices are intended to function in place of human readers for interpreting digital chest X-rays. To qualify, such products must receive a policy assessment endorsement from the WHO Department for HIV, TB, Hepatitis, and Sexually Transmitted Infections (HTH).

Did You Know? The WHO’s work in prequalification for medical devices began in 2011–2012, initially focusing on male circumcision devices to support HIV prevention efforts alongside existing procedures for in-vitro diagnostics (IVDs).

Implications for Manufacturers and Global Access

The new eligibility criteria place a high premium on manufacturing rigor. For reproductive health devices like condoms and IUDs, applicants must prove they control key production stages, such as formulation, dipping, or sterilization. Agents or distributors that only handle packaging or testing are no longer eligible to apply, ensuring that the entities responsible for core product integrity are directly accountable to the WHO.

Expert Insight: By centralizing these assessments, the WHO is likely looking to create a more unified global benchmark for quality. For stakeholders, the shift means that while the path to approval may be more stringent, products that successfully navigate this process will carry a higher level of international credibility, potentially facilitating broader integration into national health systems.

What May Happen Next

As the WHO integrates these new device categories, we will see a shift in the global supply chain for reproductive health and TB screening tools. Manufacturers of other medical device types not currently listed may begin reaching out to the WHO to inquire about future eligibility criteria. Because the WHO confirms eligibility only after reviewing a pre-submission form, applicants should expect a detailed verification process before their products are even considered for assessment.

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Frequently Asked Questions

Which medical devices are now eligible for WHO prequalification?
The list now includes male circumcision devices, computer-aided detection (CAD) software for TB screening, male latex condoms, female condoms, and copper-bearing intrauterine devices (Cu-IUDs).

Can a distributor apply for the prequalification of condoms?
No. Agents, distributors, or suppliers engaged only in testing, lubricating, or primary packaging are not eligible to apply. Manufacturers must perform core processes like formulation and dipping.

How does the WHO ensure the quality of IUDs?
Manufacturers must undertake the molding, assembly, packaging, and control of sterilization. While some processes can be contracted out, the manufacturer retains overall responsibility for the quality of the finished product.

How might the centralization of these assessments change the way health ministries select medical devices for their populations?