In vitro diagnostics and laboratory technology

Prequalification of in vitro diagnostics product dossier review

The manufacturer should compile and submit the product dossier as prescribed by the WHO document "PQDx_018 Instructions for Compilation of a Product Dossier". WHO reviews the product dossier with the purpose of:

• Assessing evidence in support of safety and performance of the product;

• Determining if the manufacturer’s quality management system is of an adequate standard to warrant an inspection of the manufacturing site;

• Assessing the product design and manufacture; and

If the dossier is not complete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier is accepted, the prequalification will proceed to the laboratory evaluation and the manufacturing site inspection.