Tools and Guidance

Resources

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 Medical Product Alert for falsified Uni-Gold HIV (No 2, 2020, version 2)
Author : WHO
Document Category : Guidance for end-users
WHO overview of prequalification of IVDs assessment
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO prequalification performance evaluation protocols
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO risk based approach for the assessment of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO risk based classification of diagnostics for WHO prequalification
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO status of IVD undergoing WHO prequalification
Author : WHO
Document Category : Guidance for end-users
WHO technical guidance series 1 - standards applicable to WHO Prequalification of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO technical guidance series 2 - establishing stability of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers