WHO PQDx is a valuable initiative that improves the quality of in vitro diagnostics for under-served populations in countries where regulatory systems are weak or non-existent. However, broader attention to some of the existing inefficiencies and longer-term risks concerning the successful implementation of this important programme is needed. Our viewpoint discusses challenges of WHO PQDx, in particular around its scope, processes, timelines and financing. It also highlights the manufacturers’ responsibilities and is informed by consolidated feedback from a large number of experts working in the in vitro diagnostics and medical devices industries, along with insightful comments from WHO. The paper was accepted for publication on 17 August 2017 and assigned to Clinical Infectious Diseases’ 6 January 2018’s issue. It is freely available at https://doi.org/10.1093/cid/cix719.
