Resources

WHO Medical Product Alert for falsified Uni-Gold HIV (No 2, 2020, version 2)

Author : WHO

Topic : Post-market surveillance

Type of document : WHO information notice for users

Document Category : Guidance for end-users

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WHO guidance for procurement of IVDs and related laboratory items and equipment

Author : WHO

Topic : Maintenance , Procurement , Product selection

Type of document : Guidelines

Document Category : Guidance for end-users

Technical Specification Series to WHO Prequalification - Diagnostics Assessment: HIV rapid diagnostic tests for professional use and/or self-testing

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO manual for organizing a national external quality assessment programme for health laboratories and other testing sites

Author : WHO

Type of document : Guidelines

Document Category : Guidance for end-users

WHO technical guidance series 4 - test method validation for IVDs

Author : WHO

Topic : WHO Prequalification

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

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO guidelines on hepatitis B and C testing

Author : WHO

Topic : Product selection

Type of document : Guidelines

Document Category : Guidance for end-users

WHO risk based classification of diagnostics for WHO prequalification

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO IVD complaint form

Author : WHO

Topic : Post-market surveillance

Document Category : Guidance for end-users

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