Eligibility criteria for WHO prequalification of in vitro diagnostics, seventh edition. Prequalification of in vitro diagnostics

This guide provides guidelines for the prequalification of in vitro diagnostic (IVD) medical devices by the World Health Organization (WHO). The primary focus of this prequalification is on IVDs for priority diseases, especially those suitable for resource-limited settings. The WHO prequalification process involves a comprehensive quality assessment to determine if a product meets the required standards. This includes reviewing a full product dossier, performance evaluation, manufacturing site inspection, and labelling review.

Manufacturers wishing to apply for prequalification must be the original producers of the product. Rebranded products, often known as original equipment manufacturer (OEM) products, are not eligible for prequalification. Additionally, only products that are commercially available at the time of submission are considered.

The eligibility criteria are based on the need for IVDs for specific diseases, their appropriateness for use in limited-resource settings, requests from WHO Member States, recommendations in WHO testing guidelines, and the availability of similar prequalified products. Products that successfully pass the assessment are included in the WHO list of prequalified IVDs, and their status remains valid as long as manufacturers meet post-qualification obligations and requirements. The document serves as a reference for manufacturers and stakeholders to understand the criteria and process for WHO prequalification of IVDs.