WHO Prequalification of Male Circumcision Devices
The aim of the WHO Prequalification of Male Circumcision Devices Programme is to promote and facilitate access to safe, appropriate and affordable Male Circumcision Devices of good quality in an equitable manner. The findings of the WHO Prequalification of Male Circumcision Devices Programme are used to provide technical information principally to other United Nations (UN) agencies, but also to WHO Member States and other interested organizations, on particular Male Circumcision Devices.
The WHO Prequalification of Male Circumcision Devices is a procurement-driven programme that aims to ensure cost-effective use of resources.
- The product dossier is reviewed with the purpose of gaining an understanding of the product and how it performs.
- The manufacturing site inspection is carried out to assess the adequacy and effectiveness of the manufacturer’s quality management system and the correct implementation of documented procedures.
- The objective of the clinical study is to assess the safety and performance/efficacy of the device in question and evaluate whether the device is suitable for the purpose(s) and the population(s) for which it is intended.
If a product meets the prequalification requirements then it can become eligible for inclusion in UN procurement tenders.