COVID-19 self-test kits authorised for use in Singapore

COVID-19 diagnostic tests previously authorised under the Pandemic Special Access Route (PSAR) have moved to full-fledged product registration.

The current list of COVID-19 diagnostic tests registered in Singapore can be found on the SIngapore Medical Device Register (SMDR). 

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.