Change Reporting Form for a WHO Prequalified Male Circumcision Device. Geneva: World Health Organization; 2019
(2019; 24 pages)

Abstract

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.

 
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