History

In 1988, WHO launched the Test Kit Evaluation Programme after finding that HIV diagnostic tests developed in Europe and the USA performed poorly in African populations. The programme assessed assay quality using specimen panels from diverse geographical regions to ensure reliable performance across populations. It later expanded to include other diseases.

As more diagnostic assays entered the market—and many manufacturers moved production to countries with weaker regulations—WHO established a Prequalification Programme for In Vitro Diagnostics (IVDs) and Medical Devices in 2010. This programme focused on priority diseases and adapted to the rapidly evolving diagnostics landscape.

Since 2010, WHO’s prequalification assessments have expanded in scope and diversity, alongside growing global regulatory convergence. In 2026, WHO is revising its prequalification process to improve timeliness, transparency, and responsiveness. From 2026, WHO’s performance evaluation which was once a component on WHO’s prequalification assessment is now a separate, prerequisite step to prequalification, with both processes coordinated under WHO Prequalification.

Prequalification of male circumcision devices

WHO’s prequalification of male circumcision devices (MCDs) started in 2011, to support of HIV prevention programmes. The initiative aims to promote equitable access to safe, appropriate, affordable, and quality-assured MCDs. Evaluation results form the basis for WHO’s technical recommendations, which are shared primarily with UN agencies, as well as WHO Member States and other partners. 

Vision and mission

WHO’s Prequalification of In Vitro Diagnostics (IVDs) aims to make quality, safe, and effective IVDs and medical devices accessible to everyone.

The WHO Prequalification of In Vitro Diagnostics (IVDs) team works to expand access to affordable, quality-assured diagnostics and medical devices, supporting Universal Health Coverage and Sustainable Development Goal 3: good health and well-being for all.

Strategy

WHO's strategy for achieving this vision incorporates:

• application of internationally-recognized standards and best international regulatory review practice with respect to the evaluation of quality, safety and performance of IVDs and medical devices.
• prequalification of IVDs and MCDs through comprehensive evaluation of their quality, safety and performance and suitability for use in resource-limited settings. This process  is based on assessment of information submitted by the manufacturers, and inspections of manufacturing sites.

Key outputs

The outputs of WHO prequalification of IVDs and MCDs are the:

• WHO List of Prequalified In Vitro Diagnostic Products
• WHO List of Prequalified Male Circumcision Devices
• WHO Public Assessment Reports
• WHO Public Inspection Reports