Prequalification of Male Circumcision Devices Dossier Review
WHO reviews the product dossier with the purpose of assessing the product and how it performs, assessing the product manufacture and determining if the manufacturer's quality management system is of an adequate standard to warrant a WHO prequalification site inspection.
Once the product dossier has been received by WHO, it is screened for completeness and provided it contains all the required information, it undergoes a full review. If the product dossier is incomplete, the manufacturer is informed that an incomplete product dossier has been received and is requested to complete it within a specified time period.