News
5 May, 2025 - 10:37 (CEST)
Announcement
IVD
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for:
- Screening for/diagnosis of anaemia;
- Aid in the diagnosis of anaemia;
- Aid in diagnosis of severe anaemia in patients with malaria; or
- Monitoring of haemoglobin levels.
The respective guidance document has been updated and posted on the WHO website Eligibility criteria for WHO prequalification of in vitro diagnostics (PQDx_298 v9, March 2025) of haemoglobin PoC analysers.
Interested in WHO prequalification assessment are invited to contact the WHO PQ Unit at diagnostics@who.int to schedule a pre-submission call.