COVID-19 Test Kits Authorised for Professional Use
With effect from 1 January 2022, only COVID-19 tests that have received full-fledged registration with HSA or have been authorised under the Pandemic Special Access Route (PSAR) shall be supplied in Singapore.
The COVID-19 tests that have received full-fledged registration with HSA are listed on the Singapore Medical Device Register (SMDR). This register can be accessed online here.
Where there are tests that have not been registered on SMDR as yet, and the Ministry of Health (MOH) determines that there is a clinical need for the use of these tests, MOH designates these tests as “emergency medical devices”. Only these tests would qualify for authorisation under the PSAR. HSA evaluates to determine if these tests meet the essential standards of safety, quality, and efficacy as appropriate prior to granting authorisation under PSAR.
The following COVID-19 diagnostic tests have been authorised for Professional Use by HSA under PSAR. These tests shall only be supplied to healthcare institutions, private hospitals, medical clinics, or clinical laboratories licensed under the PHMC Act (Cap. 248) for use on their patients.
Molecular Tests
Antigen Tests
Antibody (Serology) Tests
Other Tests
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Healthcare professional, Industry member, Medical devices
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