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PQDx_119 Reportable changes to WHO prequalified and EUL IVD & non-IVD Medical Devices DOCX

Template

IVD

MD

PQDx_121 Guidance Reportable Changes PDF

MD

PQDx_464 WHOs prequalification procedure for medical devices PDF

MD

PQDx_465 Eligibility criteria for PQ MDs PDF

MD

PQDx_466 Pre-submission form for WHO’s prequalification assessment of medical devices DOCX

MD

PQDx_467 Instructions for completion of the PSF for WHO’s PQ assessment of MDs PDF

MD

PQDx_468 TOC Instructions for compilation of a product dossier for MDs PDF

MD

PQDx_469 Product dossier checklist for WHO’s prequalification of medical devices DOCX

MD

PQDx_470 Abridged prequalification assessment for medical devices PDF

MD

PQDx_471 Prequalification Fees for medical devices PDF

ID

IVD

MD

PQMD launch summary PDF

Information note

MD

WHO BDBV EUL Public Report for Ebola Virus (EBOV) Real Time RT-PCR Kit, (EUL 14468-139-00) PDF

Report

MD

WHO Prequalification of medical devices FAQs PDF

Information note

Recently Updated Documents

WHO Prequalification of medical devices FAQs

PQDx_119 Reportable changes to WHO prequalified and EUL IVD & non-IVD Medical Devices

PQDx_121 Guidance Reportable Changes

Notes on the Design of Bioequivalence Study: Cyclophosphamide

Notes on the Design of Bioequivalence Study: Etoposide

WHO Technical Report Series Location

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found in the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible on the WHO Technical Report Series page.