Singapore HSA has announced below medical devices regulatory changes related to IVDs, effective 2 June 2026.
1. Change in risk classification of COVID-19 IVDs
During the pandemic, COVID-19 IVDs were classified as Class D due to SARS-CoV-2 being a transmissible agent causing life threatening disease with high propagation risk. With COVID-19’s transition to endemic status, the virus now presents moderate rather than high public health risk. Whilst propagation risk has significantly decreased, serious illness remains possible.
HSA has reclassified COVID-19 IVDs from Class D to Class C to ensure regulatory oversight remains appropriate to current risk levels with effect from 2 June 2026. HSA’s classification adopts a cautious, stepwise approach while maintaining appropriate controls for devices that may still pose significant individual health risks, particularly for vulnerable populations.
Requirements will now be aligned with other Class C infectious disease IVDs, ensuring continued safety and efficacy standards while reducing regulatory burden proportionate to the current endemic status of COVID-19.
2. IVD Cluster Grouping Restructuring
HSA obsoleted the “IVD Cluster” grouping from GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria. “IVD Cluster” grouping is no longer fit for purpose and losing relevance in today’s regulatory environment.
Updated guidance GN-12-1 can be viewed in the following link: https://file.go.gov.sg/gn-12-1-r3-02-06-2026.pdf