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Health Sciences Authority

Grouping medical devices as an IVD Cluster

With effect from 2 June 2026, HSA will be obsoleting the "IVD Cluster" grouping currently found in GN-12-1. This change is part of HSA's ongoing efforts to streamline and improve the classification and grouping framework for In Vitro Diagnostic (IVD) medical devices.

Last updated 28 May 2026

Industry Input Opportunity

HSA welcomes feedback from industry stakeholders on the potential addition of new specific categories in GN-12-2. An industry feedback form is available on the HSA website for relevant stakeholders to submit their views.

The feedback window is open until 31 July 2026. We encourage all relevant stakeholders to take this opportunity to contribute to the development of a more comprehensive and fit-for-purpose grouping framework.

Submit Your Feedback for IVD-Related Device Specific Grouping to GN-12-2