Eligibility criteria for WHO prequalification of in vitro diagnostics. Version 3. Geneva: World Health Organization; 2018 - Prequalification of in vitro diagnostics
(2018; 5 pages)

WHO Prequalification of In Vitro Diagnostics undertakes a comprehensive assessment of individual in vitro diagnostics (IVDs) through a standardized procedures aimed at determining if the product meets WHO prequalification requirements. In addition, once a product is prequalified, WHO assesses all reportable changes to verify that the product continues to meet WHO prequalification requirements. This document has been prepared to provide manufacturers and other stakeholders with an overview of the eligibility criteria applied to products submitted for WHO prequalification assessment of IVDs. It is recommended that manufacturers wishing to apply for WHO prequalification of their product(s) read this document before applying for prequalification.
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