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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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 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
Healthcare professional, Industry member, Medical devices
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