Tools and Guidance

Resources

Global Fund list of IVDs meeting Global Fund QA policy
Author : Global Fund
HIV Early Infant Diagnosis and Viral Load POC Diagnostics: Market and Supply Update, March 2020
Author : UNICEF
Topic : Procurement
Document Category : Guidance for manufacturers
Lignes directrices pour la surveillance post commercialisation des dispositifs médicax de diagnostic in vitro
Author : WHO
Type of document : Guidelines
Document Category : Guidance for end-users
Lignes directrices pour l’achat de dispositifs médicaux de diagnostic in vitro et articles et équipements de laboratoire connexes
Author : WHO
Type of document : Guidelines
Document Category : Guidance for end-users
Sample product dossier for a qualitative nucleic acid‑based testing technology for HIV-1 and HIV-2
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
Sample product dossier for a quantitative nucleic acid-based testing technology to measure HIV-1 RNA
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
Sample product dossier for CD4 enumeration technology
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
Technical Specification Series to WHO Prequalification - Diagnostics Assessment: HIV rapid diagnostic tests for professional use and/or self-testing
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
UNICEF supply catalogue for diagnostics
Author : UNICEF