- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > prequalification - eligibility for prequalification assessment
- Keywords > prequalification - In Vitro Diagnostics assessment
- Keywords > prequalification - IVDs for use in treatment programmes
- Keywords > prequalification - vaccines, medicines, diagnostics and medical devices
- Keywords > prequalification of diagnostics
- Keywords > prequalification process
- Keywords > Product Dossier (PDs) - compilation
- Keywords > in vitro Diagnostic (IVD)
(2014; 13 pages)
The WHO Prequalification of IVDs Programme undertakes a comprehensive assessment of individual in vitro diagnostics through a standardized procedure aimed at determining if the product meets WHO prequalification requirements.
The prequalification assessment process includes three components:
- Review of a product dossier
- Laboratory evaluation of performance and operational characteristics
- Manufacturing site(s) inspection
There are many terms used internationally to describe a product dossier. These terms include: standard technical documentation, technical file, summary technical documentation, product summary file, product master file and others. For the purposes of prequalification of IVDs, WHO uses the term the product dossier.
The product dossier is a selection of records and documents from this entire collection of records and documents that a manufacturer holds for a product. Manufacturers compile a product dossier from their existing technical documentation to provide evidence that the IVD conforms to the internationally recognized set of safety and performance principles as described in the Global Harmonization Task Force document GHTF/SG1/N68:2012 “Essential Principles of Safety and Performance of Medical Devices”.
This document has been prepared to assist manufacturers in correctly compiling a product dossier for the purposes of WHO prequalification assessment of IVDs, and describes the required product dossier information to support WHO Prequalification of IVDs. This document should be used together with WHO Document PQDx_049 “Product Dossier Checklist”. Manufacturers who wish to submit a product dossier for an IVD should read both documents carefully to compile a successful product dossier.