Reportable Changes to a WHO Prequalified In Vitro Diagnostic Medical Device
(2016; 24 pages)

Abstract

This document aims to provide manufacturers of WHO prequalified in vitro diagnostic medical devices (IVDs) with information on when they must report to WHO about:

  • changes to the prequalified product or its manufacture;
  • changes to the Quality Management System (QMS) that the product was designed and manufactured under; and/or
  • other reportable administrative changes.

Manufacturers of WHO prequalified IVDs should read and understand this document so that they are aware of their duties and responsibilities as a supplier of a prequalified IVD as to when to report to WHO applicable changes to the IVD, its manufacture and other related activities.

This document describes when and how a manufacturer will report to WHO changes to a prequalified IVD and its manufacture, the QMS under which it is manufactured and certain administrative changes associated with the IVD. 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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