HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection, to address the urgent need for timely detection of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.
From 01 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 tests. All new tests for supply in Singapore should be submitted for full-fledged registration.
For all COVID-19 tests granted provisional authorisation, the provisional authorisation will remain valid only till 31 December 2021.
For new tests that are not registered with HSA in 2021, the Ministry of Health (MOH) will determine if there is a clinical need for the use of these tests. From 01 January 2022, MOH would consider designating these tests as “emergency medical devices”. Only such tests would qualify for the Pandemic Special Access Route (PSAR).
From 01 January 2022, all COVID-19 tests supplied in Singapore should have received full-fledged registration approval from HSA, or received authorisation under the Pandemic Special Access Route (PSAR).
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