- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Tous > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Mots-clés > good quality in vitro diagnostics (IVDs)
- Mots-clés > IVDs prequalification assessment - fees and change assessment fees
- Mots-clés > prequalification - eligibility for prequalification assessment
- Mots-clés > prequalification - In Vitro Diagnostics assessment
- Mots-clés > prequalification - IVDs for use in treatment programmes
- Mots-clés > prequalification - vaccines, medicines, diagnostics and medical devices
- Mots-clés > prequalification of diagnostics
- Mots-clés > prequalification process
- Mots-clés > requalification - changes to a prequalified IVD and its manufacture
- Mots-clés > in vitro Diagnostic (IVD)
(2016; 24 pages)
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.