July 1, 2021
Singapore’s Health Sciences Authority (HSA) has announced significant new developments related to authorizations for COVID-19 test kits.
HSA stops accepting new provisional authorization (PA) applications for COVID-19 test kits
The HSA posted an update to the page on its website covering provisional authorizations (PAs) for COVID-19 test kits, announcing that it is no longer accepting PA applications for COVID-19 test kits as of June 1, 2021. Consequently, these test kits must now undergo either a full-fledged premarket registration or the Pandemic Special Access Route (PSAR) authorization in order to be imported and to be clinically used in Singapore.
The HSA also noted that PA approvals for COVID-19 test kits that have already been granted (there is a full list on the same web page) will remain valid until December 31, 2021. Beginning on January 1, 2022, only COVID-19 tests that are approved via full-fledged registration or PSAR authorization can be supplied in Singapore. For new tests (not registered in 2021) to qualify for PSAR authorization, the Ministry of Health (MoH) must first determine that there is a clinical need for such tests and designate them as "emergency medical devices."
For more details, the HSA provides information on full-fledged registration and PSAR authorization on its website.
HSA details authorization process for COVID-19 antigen rapid test (ART) self-test kits
The HSA has provided an overview of the recently applied process for authorizing COVID-19 antigen rapid test (ART) self-test kits for use in Singapore.
The process begins with the MoH determining whether there is a clinical need for the ART and designating it for HSA evaluation under the PSAR. After that, the HSA will evaluate the ART based on data provided by the manufacturer. If the HSA determines that the ART meets the appropriate standards of safety, quality, and efficacy, it will grant PSAR authorization.
To support adequate performance of PSAR-authorized ARTs, the HSA requires companies to collect relevant accuracy and safety data and to monitor the use of their ARTs. The HSA also requires the submission of additional data from ongoing clinical studies following approval. Companies must take the required follow-up actions if any safety or performance issues come to light.
Finally, the HSA encourages consumers to only purchase authorized ARTs. More information is available in an HSA press release announcing the interim authorization of the first four ARTs. An up-to-date list of authorized ARTs can be found on the same page as the overview cited above; as of this writing, there is now a fifth ART with interim authorization.
More medical device regulatory resources for Singapore from Emergo by UL:
- Singapore HSA medical device registration and approval consulting
- Medical device classification in Singapore
- Singapore Registrant in-country representation services
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