ID IMD-TP-05b Standard letter B -Notification of major changes to verification protocol PDF Guideline/guidance
ID IMD-TP-06a Standard letter A - Notification verification protocol withdrawal PDF Guideline/guidance
ID IMD-TP-07c Example format for an IMD-PQS-accredited test laboratory data sheet PDF Guideline/guidance
ID IMD-TP-10a Standard letter A - Notification of problems identified during product re-evaluation PDF Guideline/guidance
ID IMD-TP-10b Standard letter B - Notice of suspension of prequalification status PDF Guideline/guidance
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
IVD Information for manufacturers on the inspection of manufacturing sites: Prequalification of male circumcision devices (PQDx_014 V4, Version MC_0, 15 November 2012) PDF Guideline/guidance
IS Information Note - Mylan Laboratories Ltd (Viatris, Inc.) Indore, Pithampur, India (31 March 2025) PDF Information note
M Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility PDF Information note
IVD Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting antibodies to SARS-CoV-2 virus PDF Guideline/guidance
IVD Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting SARS-CoV-2nucleic acidandrapid diagnostics tests detecting SARS-CoV-2 antigens PDF Guideline/guidance
IVD Instructions for compilation of a product dossier (PQMC_018 v1, 23 January 2012) PDF Guideline/guidance
IVD Instructions for submission requirements: in vitro diagnostics (IVDs) detecting antibodies to Zika virus (PQDx_239 v4, 28 October 2016) PDF Guideline/guidance
IVD Instructions for submission requirements: in vitro diagnostics (IVDs) detecting Zika virus nucleic acid or antigen (DxPQ_240 version 3, 24 October 2016) PDF Guideline/guidance
IVD Instructions for the completion of the pre-submission form for application for prequalification of an in vitro diagnostic PDF Guideline/guidance