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It will be updated as more tests gets approved: No. The Table below lists the COVID-19 tests that have received provisional authorisation to date. If you have any questions regarding this provisional authorisation process, please contact us here.
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HSA would evaluate to determine if these tests meet the appropriate standards of safety, quality and efficacy applicable to these tests and authorise these tests under the PSAR.įor all COVID-19 tests granted provisional authorisation, the provisional authorisation will remain valid till 31 December 2021.įrom 1 January 2022, only diagnostic tests which have received full-fledged registration approval with HSA, or authorisation under the Pandemic Special Access Route (PSAR), shall be supplied in Singapore Only such tests would qualify for the Pandemic Special Access Route (PSAR).
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Where there are new tests that are not registered with HSA in 2021 and the Ministry of Health (MOH) determines that there is a clinical need for the use of these tests from or after 1 January 2022, MOH would consider designating these tests as “emergency medical devices”. You can find more information on product registration here. All new tests for supply in Singapore should be submitted for full-fledged registration. From 1 January 2022, all COVID-19 tests supplied in Singapore should be registered with HSA or received authorisation under the Pandemic Special Access Route (PSAR).įrom 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 tests.
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For tests that have been granted provisional authorisation, the authorisation will remain valid till 31 December 2021.From 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 test.This provisional authorisation has been implemented as an interim measure in response to the current public health need for timely detection of COVID-19 infections. If any safety or performance issues are observed, HSA will require relevant follow up actions at the manufacturer’s end. Periodic reports on specific data on the safety and/or performance of these tests will be required to be submitted to HSA post authorisation to assure the continued performance of these devices. Limit of detection, cross reactivity, inclusivity). primers and probe design, target sequence in the viral RNA) and the supporting validation data 122 KB (e.g. This provisional authorisation is based on a risk-calibrated review process that considers the design aspects of the test (e.g. This has helped expand the number and variety of diagnostic tests available in Singapore. To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. See Table below for more information on the diagnostic tests that we have approved to date via provisional authorisation. Since 29 January 2020, HSA has been closely providing regulatory and scientific advice to research institutions as well as local and multi-national companies to ensure the timely availability of good quality performing test kits that are critical during this period of need. The Health Sciences Authority (HSA) is committed to ensuring the rapid availability of diagnostic tests for COVID-19 in Singapore. HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation