WHO Prequalifications for IVDs

We support manufacturer applications for WHO prequalification, the Global Fund Expert Review Panel for Diagnostics and the WHO Emergency Use Listing procedure. In addition to application support, our experts provide guidance for clinical trial design, technical file preparation and the robust development of quality management systems.

In vitro diagnostic products (IVDs) fulfill a key role for low- and middle-income countries (LMICs) in preventing and controlling the spread of diseases like HIV, malaria and Ebola.

We support manufacturer applications to the WHO prequalification process for including IVDs in UN procurement tenders. Our team of experts reviews your product dossiers, safety details and performance testing results. Prepare for site inspections to ensure compliance with ISO 13485:2016, as well as requisite laboratory evaluations, with the help of former regulatory staff and industry experts.

The Global Fund is dedicated to fighting communicable diseases in countries with few resources or developing infrastructure. It receives public funding from governments around the world, as well as private donations from organizations like the Bill and Melinda Gates Foundation.

NSF assists manufacturers with submissions to the Global Fund’s Expert Review Panel for Diagnostics. These submissions must include performance data, evidence of product registration or marketing authorization, WHO prequalification status (if applicable) and details of relevant quality management systems.

NSF assists manufacturers with submissions to the WHO Emergency Use Listing (EUL) procedure for coronavirus testing. This procedure ensures expedited IVD product review using minimum available sets of quality, safety and performance data.

Please contact us for further details on any of the above services, or for exploratory discussions on the most effective route for IVD evaluation by WHO, the Global Fund or other bodies involved in procurement for LMI countries.