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(2019; 24 pages)
This document aims to provide manufacturers of WHO prequalified male circumcision devices with information on when they must report to WHO about:
- changes to the prequalified device or its manufacture;
- changes to the Quality Management System (QMS) that the device is designed and manufactured under; and/or
- other reportable administrative changes.
Manufacturers of WHO prequalified male circumcision devices should read and understand this document so that they are aware of their duties and responsibilities as a supplier of a prequalified male circumcision device as to when to report to WHO applicable changes to the device, its manufacture and other related activities.
This document describes when and how a manufacturer will report to WHO changes to a prequalified male circumcision device and its manufacture, the QMS under which it is manufactured, and certain administrative changes associated with the device. To assist the understanding of when to report a change to WHO, this document provides guidance and a non-exhaustive list of generic examples.