In vitro diagnostics and laboratory technology

Pre-submission form

The manufacturer should complete the pre-submission form “PQDx_015 Pre-Submission Form” and provide all supportive documentation as requested in accordance with the WHO document "PQDx_017 Instructions for the Completion of the Pre-submission Form".

A completed pre-submission form provides summary information about the product, its regulatory version and the manufacturer. The information contained within this form will inform WHO in its decision to prioritize the product submitted for prequalification or not.