The World Health Organization has expanded its medical-device prequalification programme to cover a wider range of health technologies, including contraceptive devices, tuberculosis screening software and male circumcision devices.

The expansion is designed to help countries identify medical devices that meet international standards for quality, safety and performance, particularly where national regulatory systems have limited capacity.

The updated programme creates a broader international assessment mechanism for products that are important to public health and disease prevention.

Wider Range of Medical Devices

The WHO prequalification programme previously covered selected medical technologies, including in vitro diagnostics and male circumcision devices under separate arrangements.

The expanded framework now includes male and female condoms, copper-bearing intrauterine devices, computer-aided detection software for tuberculosis screening and male circumcision devices.

The products will undergo standardized assessment before they can be included on the WHO list of prequalified medical devices.

Supporting Countries With Limited Regulatory Capacity

A major objective of the expansion is to support countries where national regulatory systems may not have sufficient resources to independently evaluate every medical product.

WHO says that around 70 percent of countries report inadequate or weak regulatory systems for medicines and vaccines, with regulatory challenges also affecting other health products.

An internationally recognized prequalification system can provide procurement agencies and national authorities with additional information when selecting medical devices.

Contraceptive Devices Included

The programme now incorporates the prequalification of male and female condoms as well as copper-bearing intrauterine devices.

These products are important components of sexual and reproductive healthcare.

Quality assurance is particularly important because contraceptive devices are used by millions of people and must meet appropriate standards for safety, effectiveness and manufacturing quality.

The transfer of prequalification responsibilities for these products from the United Nations Population Fund to WHO forms part of the programme’s expansion.

Artificial Intelligence for TB Screening

Another important addition is computer-aided detection technology for tuberculosis screening.

These systems use digital chest X-rays and artificial intelligence to identify people who may have tuberculosis and require additional testing.

The technology could be particularly useful in countries with a high burden of tuberculosis, where screening large populations can be challenging.

By including eligible CAD-TB technologies within the prequalification framework, WHO is creating a standardized pathway for evaluating their quality and performance.

Male Circumcision Devices

Male circumcision devices have also been incorporated into the broader medical-device prequalification system.

WHO states that prequalified devices can support safe and standardized voluntary medical male circumcision services in countries and settings where such interventions are used for HIV prevention.

The devices must meet the relevant clinical and technical requirements before being considered for WHO prequalification.

Independent Assessment

WHO’s medical-device prequalification process is based on an independent and standardized assessment.

Depending on the product and assessment pathway, the process can include examination of technical documentation, manufacturing-site inspections and review of product labelling.

A device is considered for listing only after the required assessment components have been completed.

This provides procurement organizations and health authorities with a common reference when considering eligible products.

Initial Assessment Timeline

WHO’s updated eligibility information sets out different timelines for various categories.

Products previously submitted through the UNFPA system, along with eligible CAD-TB products and male circumcision devices, can begin WHO assessment from 1 October 2026.

Contraceptive devices that were not previously submitted to and accepted by UNFPA will become eligible for WHO assessment from 1 April 2027.

Importance for Global Health

Medical devices play a central role in healthcare, from disease screening and diagnosis to prevention and treatment.

The WHO says there are an estimated 2 million different types of medical devices on the global market, divided into more than 7,000 generic device groups.

The large and diverse medical-device market makes effective regulation and quality assurance particularly important.

Improving Procurement Decisions

The expanded prequalification programme is also expected to provide additional support to United Nations agencies, donors, procurement organizations and national health authorities.

A WHO prequalification listing does not replace national regulatory requirements, but it provides an internationally recognized assessment of eligible products.

This can help countries make more informed procurement decisions, particularly where technical evaluation resources are limited.

Digital Health Enters a New Phase

The inclusion of AI-supported tuberculosis screening technology also reflects the growing role of digital tools in healthcare.

As artificial intelligence becomes increasingly integrated into diagnosis and screening, governments need mechanisms to assess the safety, quality and performance of these technologies.

The new framework gives such technologies a pathway into the international health-product assessment system.

Looking Ahead

The expansion marks a broader approach to medical-device quality assurance at the international level.

By bringing reproductive-health products, TB screening technologies and male circumcision devices into an expanded prequalification framework, WHO is seeking to improve access to health technologies that meet established standards.

The next stage will involve manufacturers submitting eligible products for assessment and WHO conducting technical evaluations.

For countries with limited regulatory capacity, the programme could provide an additional source of trusted information when selecting medical technologies for public-health programmes.