COVID-19 self-test kits authorised for use in Singapore
Consumer, Healthcare professional, Industry member, Medical devices, Medical devices
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 29 March 2023.
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.
For COVID-19 diagnostic tests authorised under PSAR, distributors should prepare to transition to full registration for their tests.
Full Registration Requirements for COVID-19 Tests
For registration submission requirements, please refer to the below guidance documents which can be found here:
- GN-18 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT” under header Product Registration
- TR-02 Contents of a Product Registration Submission for In-Vitro Diagnostic Medical Devices using the ASEAN CSDT” under header Technical Reference Documents
The above guidance documents include requirements applicable for all clinical diagnostic tests based on different technologies. Therefore, for each diagnostic test depending on the methodology and intended purpose of the test, the manufacturer should validate their test for the relevant parameters described in the documents that are relevant to their test.
In addition, some of the key validation requirements applicable for full registration of COVID-19 self-tests are summarised in the pdf file below:
Validation Requirements for Product Registration of COVID-19 Diagnostic Tests – Self-Tests.pdf183 KB