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 selected male circumcision devices.
The WHO Prequalification of Male Circumcision Devices is a procurement-driven programme that aims to ensure cost-effective use of resources.
PQMC Prequalification Process
- The product dossier is reviewed with the purpose of gaining an understanding of the product, its safety and performance, design and manufacture; and determining if the manufacturer’s QMS is of an adequate standard to warrant an inspection.
- The manufacturing site inspection is carried out to assess compliance with the quality management standard ISO 13485:2003, with focus on the suitability of the implemented processes and procedures for the reliable supply of products.
- 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.