Overview

WHO Prequalification of Medical Devices

WHO prequalification (PQ) is a standardized process that assesses individual health products to confirm they meet WHO's requirements for quality, safety and performance.

The process focuses on products that address major public health priorities and are suitable for use in resource-limited settings. It includes:

•    Review of product documentation and supporting evidence
•    Assessment of manufacturing quality systems
•    Ongoing oversight after a product is prequalified

A NEW Chapter: Medical Devices Join WHO Prequalification 

On 25 September 2026, WHO launched prequalification assessments for medical devices — expanding the range of health products covered by WHO PQ and strengthening access to safe, effective, quality-assured technologies worldwide.

This milestone supports evidence-based procurement by UN agencies, international organizations and Member States, through a transparent process that keeps resource-limited settings in focus.

Background

WHO began prequalifying male circumcision devices in 2011–2012, to expand access to quality-assured circumcision as an HIV prevention tool in high-incidence, low-prevalence settings. This built on WHO's existing prequalification work for in vitro diagnostics (IVDs).

Scope

The following product categories are now eligible for assessment:
•    Male latex condoms
•    Female condoms
•    Intrauterine devices (IUDs)
•    Computer-aided detection software for TB screening (CAD-TB)
•    Male circumcision devices (previously assessed under a separate process)

A Harmonized Framework for Contraceptive Devices

Assessment of contraceptive devices — formerly handled by United Nations Population Fund (UNFPA) — has now moved to WHO. This brings all priority health product assessments under one roof, promoting consistency and efficiency.

Contraceptive devices will be assessed using a framework aligned with WHO's established PQ approach (including IVDs), backed by internationally recognized standards and structured dossier requirements.

For all questions related to prequalification of medical devices: contact diagnostics@who.int

WHO Prequalification of medical devices FAQs