The World Health Organization prequalification of in vitro diagnostics provides a comprehensive assessment of individual IVDs for quality, safety and performance and has over a decade of experience in assessing various IVDs. Many manufacturers of IVDs are based in Asia; some of these are already experienced prequalification applicants while other manufacturers of priority IVDs lack such experience
as well as the understanding of PQ and ERPD processes, international procurement and support projects. To facilitate and scale up the manufacture of quality assured IVDs in Asia a Workshop is planned to bring together manufacturers along with partner organizations, including FIND, Global Fund, PATH, UNITAID, and PEPFAR/USAID, to scale-up access to quality-assured IVDs manufactured in Asia.
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