Prequalification fees - Version 2 Geneva: World Health Organization; 2018 - Prequalification of in Vitro Diagnostics
(2018; 4 pages)

Abstract
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 provides information on the fees associated with WHO prequalification, and the payment process thereof. There are three types of fees associated with WHO prequalification: - A prequalification assessment fee per product; - An annual fee per product; and - A change assessment fee per product. The abovementioned prequalification assessment, annual and change assessment fees are non-refundable, and cover in part the cost incurred by WHO in connection with the prequalification process. This document has been prepared to provide manufacturers with detailed information on the fees applicable to WHO prequalification and the payment process thereof.
 
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