The WHO Prequalification of In Vitro Diagnostics Assessment Team would like to invite manufacturers to submit IVDs for Monkeypox virus nucleic detection for review by WHO through an emergency assessment mechanism.
Applicants are strongly encouraged to contact WHO as early as possible to discuss the specifics of the application. Applications are accepted only from legal manufacturers. Rebranded products are outside the scope of EUL assessment and hence not accepted for assessment.
Manufacturers who are interested in an EUL submission are invited to contact diagnostics@who.int to arrange a pre-submission meeting/call. Please note that applications will not be accepted without prior consultation with WHO.
For more information, please refer to the link below:
WHO press release: WHO urges rapid access to mpox diagnostic tests, invites manufacturers to emergency review