Update on IVD Prequalification and Dossier Assessments
Stay informed about the latest developments in In Vitro Diagnostics (IVDs) prequalification and dossier assessments. Explore the new IMDRF Table of Contents format and recent dossiers received and change requests processed. Join the upcoming virtual joint meeting on 8-10 March 2022 for valuable insights and updates.
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Presentation Transcript
Prequalification of IVDs: Update: Dossier Assessment 1 Virtual Joint Meeting 08 10 March 2022
Implementation of IMDRF Table of Contents (ToC) dossier format Dossiers now being accepted in ToC format. Dossiers must be compiled according to these instructions: https://www.who.int/diagnostics_laboratory/evaluations/200324_draft_Instru ction_for_compilation_of_a_product_dossier_pqdx_018_v4_toc.pdf Please forward any feedback regarding the new format to diagnostics@who.int 2 Virtual Joint Meeting 08 10 March 2022
Dossiers in received 2021/2022 16 dossiers received for new products in 2021/2 14 ongoing dossier assessments from before 2021 IVD 2021 2022 HCV: RDT 1 HCV: NAT 1 HIV:RDT 4 HPV:NAT 3 Malaria: RDT 4 1 HIV/HBsAg/syphilis panel 1 G6PD: RDT 1 3 Virtual Joint Meeting 08 10 March 2022
Change Requests processed in 2021/2022 2021: 70 CRs [EUL: +23] 2022: 9 CRs [EUL: +2] 4 Virtual Joint Meeting 08 10 March 2022
