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IVD

MD

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

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