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WHO Information Notice for IVD Users 2026/01
In vitro diagnostic medical devices (IVDs) manufactured by Meril Diagnostics Pty. Ltd at the Manufacturing Sites.
As part of the WHO pre- and post-prequalification product review process[2], WHO’s Prequalification Unit conducted a special (for-cause) inspection of the quality management system (QMS) at the Manufacturing Sites from 14 to 16 October 2025. A for‑cause inspection is a non-routine inspection triggered by specific concerns or evidence of potential non‑compliance or product quality issues.
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