COVID-19 self-test kits authorised for use in Singapore
This article was last updated on 6 Jan 2022.
The Health Sciences Authority (HSA) is committed to ensuring the availability of COVID-19 self-test kits that meet the required safety, efficacy and quality standards, for individuals to administer on their own. Only self-tests that the Ministry of Health (MOH) has determined to have a clinical need will qualify for HSA’s evaluation under the Pandemic Special Access Route (PSAR). HSA will then evaluate the self-tests based on accrued data from the companies to determine if they meet the appropriate standards of safety, quality and efficacy, before granting PSAR authorisation.
To ensure the continued good performance of these tests after PSAR authorisation, companies are required to collect the relevant accuracy and safety data and monitor the use of the tests. HSA will also require additional data from ongoing clinical studies to be submitted post-approval for HSA to ensure the continued safety and efficacy of these PSAR-authorised tests. If any safety or performance issues are observed, HSA will require the company to take the relevant follow-up actions.
In light of the prevailing pandemic conditions and locally available testing resources, MOH has decided that COVID-19 antigen rapid self-test kits which use nasal swab samples only will no longer be eligible for Pandemic Special Access Route (PSAR) submission. From 15 March 2022, applicants who wish to supply these COVID-19 antigen rapid self-tests locally are advised to apply for full-fledged registration with HSA. Further information on full-fledged registration can be found here.
Consumers are advised to only purchase and use tests that have been authorised by HSA. As these tests are meant to be used by consumers, no doctor’s prescription is required for their purchase. These tests will be widely available through designated local retail pharmacies from 16 June 2021 and will be made available at more retail locations progressively. Consumers can refer to MOH’s guidelines on COVID-19 self-testing to ensure the correct use and appropriate follow-up actions based on the results of the self-testing.
The following self-tests have been authorised by HSA under PSAR:
This list is updated as at 17 May 2022.
Distributors who have been granted PSAR for their tests may supply their respective tests to retailers and end users of the tests but not to entities who intend to onward supply these tests by wholesale. Such entities are required to seek authorisation from HSA to perform this activity.
As of 23 December 2021, travellers coming into Singapore are allowed to bring along with them a maximum of 20 self-test kits per individual for their own testing needs. As the test kits authorised for use in Singapore may not be readily available in other countries, travellers can bring in test kits which are approved for use from their country of embarkment.