Effective July 1, 2023, the Health Sciences Authority (HSA) in Singapore has transitioned COVID-19 diagnostic tests that were previously authorized under the Pandemic Special Access Route (PSAR) to full product registration. This means that these devices must now adhere to full registration requirements and guidelines to be supplied in Singapore.
The following guidance should be adhered to during submission preparation:
- 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
Manufacturers should validate their device for the relevant parameters described in the documents depending on the applicable test, as each diagnostic test requirements are varied according to the methodology and intended purpose of the device.
HSA also provided a document that summarized some of the key validation requirements applicable for full registration of both Professional Use and Self-Test Kit COVID-19 tests. Please check the links for reference.
The COVID-19 tests that have received full-fledged registration with HSA are listed on the Singapore Medical Device Register (SMDR).
References:
Link 1: Validation Requirements for Covid-19 Tests (Self-Tests)
Link 2: Validation Requirements For Covid-19 Tests (Professional Use Only Tests)
Link 3: SMDR List
Link 4: HSA Announcement: Covid-19 Self-test Kits Authorized for Use in Singapore
Link 5: HSA Announcement: Covid-19 Test Kits Authorized for Professional Use