What We Do

⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Procedure (from 2026)

Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.

The information on this webpage reflects these upcoming changes. If you have any questions, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.

We prequalify in vitro diagnostics

WHO's prequalification of in vitro diagnostics (IVDs) assessment aims to promote and facilitate access to safe, appropriate, affordable and high-quality IVDs. The focus is on IVDs for priority diseases that are appropriate for use in resource-limited settings. WHO applies a comprehensive and standardized assessment to determine whether the IVD meets WHO prequalification requirements.

Key components of prequalification of IVD assessment:

Product dossier review
Labelling review
Manufacturing site(s) inspection

After Prequalification
Manufacturers of prequalified IVDs must:

Fulfil any outstanding prequalification commitments
Conduct post-market surveillance
Submit annual reports
Maintain compliance with relevant WHO Technical Specifications series documents
Report any changes to the product after prequalification
Pay an annual fee.

In addition WHO will undertake follow-up/surveillance inspections as part of post-qualification activities.

We prequalify male circumcision devices

WHO staff responsible for prequalification of IVDs also undertake prequalification of male circumcision devices. The approach and standards applied to prequalification of MCDs are very similar to those applied for IVD prequalification and described in the MCD section of this website.

Our key outputs

The key outputs for WHO IVD prequalification are the:

Information for

Core values of WHO prequalification

Services

Quality: We carry out — with integrity and accountability — timely and efficient prequalification of health products and other quality services in response to stakeholders' needs.

Technical principles

Evidence-base: We assess products through a transparent process, adhering to best practices and published standards, focusing on public health needs, and carrying out scientifically-sound review of all available information in support of risk-based decision-making.

Impartiality & confidentiality: We treat all manufacturers equitably — we review product quality, safety and efficacy/performance without bias — and maintain confidentiality of proprietary information.

Added-value

Expertise: We apply or convene or use our expertise to respond to the needs of patients, national regulatory agencies, Member States and industry.

Equity: We work with WHO Member States to ensure that their populations have equitable access to the good-quality health products they need.

Workplace

Ethics: We strive to create a respectful, tolerant team environment by being professional, resourceful and adaptable, in which learning is actively promoted, open communication is encouraged and good work is recognized.