Public consultation on proposed revisions to the WHO Prequalification of in vitro diagnostics assessment process

Public consultation on proposed revisions to the WHO Prequalification of in vitro diagnostics assessment process

The current prequalification assessment process for IVDs has been in place since 2014. WHO has identified the need to revise the WHO prequalification processes for IVDs and to identify opportunities for increased efficiency while preserving the quality of assessments.

WHO is seeking for public comments on the proposed revisions to the PQ assessment process for IVDs. Share your comments by 30 November 2024 and help us further shape the PQ process.

Public consultation on proposed revisions to the WHO Prequalification of in vitro diagnostics assessment process | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)


Joao Nardo

Regulatory Affairs & Quality Assurance | MDSAP & ISO 13485 Certified | Specializing in SaMD & Business Development | Empowering Medical Device Companies in the Healthcare Industry

4 个月

The global in vitro diagnostics (IVD) market was valued at approximately USD 113 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of around 5-7% over the next few years. This growth is driven by several factors, including an increasing prevalence of chronic diseases, advancements in diagnostic technologies, and the growing demand for personalized medicine and point-of-care testing. That Public consulting is very important. Thank you for sharing!

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