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Notices of Concern (NOCs) - In Vitro Diagnostics

Notices of Concern (NOCs) - In Vitro Diagnostics


The aim of the publication of a Notice of Concern is to remind the inspected entity  of its obligations to maintain quality management system procedures and continue applying good practices in accordance with international standards and norms, and to inform suppliers and procurement agencies of any potential risks associated with a given product and company. A Notice of Concern is not necessarily cause for public health alarm. However, if WHO Prequalification does identify a public health risk linked to a given product and/or company, appropriate additional measures will be taken to safeguard public health and advise the public as well as WHO Prequalification stakeholders.

A Notice of Concern will remain on this website until WHO Prequalification is satisfied that an adequate and appropriate CAPA plan has been implemented effectively by the company concerned.