Invitation to submit applications for WHO’s prequalification assessment

WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:  

• In vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid;
• Rapid diagnostic tests to detect Chlamydia trachomatis antigen; and
• Rapid diagnostic tests to detect Neisseria gonorrhoeae antigen.

For all the above products WHO’s performance evaluation is currently not required. Applicants are encouraged to read WHO’s prequalification procedure and guidance documents available on WHO’s website.  

The respective TSS documents are available on WHO’s website: 

Manufacturers planning to submit their product(s) for WHO’s prequalification assessment are invited to inform WHO of their intention, by returning the below table to diagnostics@who.int 

For any queries please contact the Assessment of Medical Devices Team at diagnostics@who.int