The manufacturer of a prequalified in vitro diagnostic (IVD) must submit to WHO an annual report for that product ‒ in a summarized form and in the format prescribed by WHO. The report must give sales details and information about any (all) categories of complaints received.
Each year the manufacturer will receive a letter from WHO requesting submission of the annual report and detailing the prescribed report format. The report for the previous calendar year must be submitted no later than 28 February. The information provided in the annual report will inform WHO’s decision as to the appropriate frequency of re-inspections.