COVID-19 Test Kits Authorised for Professional Use
With effect from 1 July 2023, only COVID-19 tests that have received full-fledged registration with HSA 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.
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 Professional Use COVID-19 tests are summarised in the pdf file below:
Validation Requirements for Product Registration of COVID-19 Diagnostic Tests - Professional Use Only.pdf224 KB
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