WHO is proud to announce the expansion in the prequalification (PQ) scope of in vitro diagnostics (IVDs). Applications for PQ can include in vitro diagnostic medical devices for monitoring of blood glucose in capillary blood and HbA1c point-of-care assays. This marks an important milestone for the Global Diabetes Compact and the public health response to the rapidly evolving epidemiology of noncommunicable diseases. Importantly, it stresses the importance of ensuring and accelerating access to good quality health products for people with diabetes.
Prequalification of in vitro diagnostics started in 2010 and has focused on high burden infectious diseases such as HIV, malaria and hepatitis with 113 IVDs currently prequalified. Global demand for high quality in vitro diagnostics is growing across multiple areas of medicine, including products on the WHO List of Essential Diagnostics.
Diabetes is recognized as a global public health issue, the 9th leading cause of death globally, with more than 420 million people living with the disease, a number that is expected to rise to 578 million by 2030 with the majority living in low- and middle-income countries. There is a critical need to scale-up efforts to prevent and treat diabetes, which was made clear by the adoption of the historic resolution on diabetes at the World Health Assembly in May 2021. WHO has developed prequalification technical specifications for in vitro diagnostic medical devices for monitoring of blood glucose in capillary blood and test strips and HbA1c point-of-care tests.
Manufacturers interested in undergoing a prequalification assessment for these products are invited to consult the WHO website to access the technical specifications and contact the in vitro diagnostics assessment team at diagnostics@who.int to schedule a pre-submission meeting. Prequalification applications will be accepted by end of Q1 2024 and a webinar for manufacturers will be scheduled soon to introduce the prequalification specifications and the assessment process. More information on the upcoming events will be provided soon.