Feb 22, 2022

The Health Sciences Authority (HSA), Singapore’s medical device market regulator, has announced new regulations regarding supplying COVID-19 test kits within the country.

Singapore HSA issues new rules for suppliers of COVID-19 test kits

Manufacturers and distributors of COVID-19 test kits within the Singapore market should take note of the latest guidance from the HSA.

The HSA announced that only COVID-19 tests that have been fully registered with the HSA can be legally distributed or sold in Singapore.

If you are a manufacturer or distributor of COVID-19 tests, you should be aware that before you distribute or sell them you must obtain a full-fledged registration with the HSA or have received authorization under the Pandemic Special Access Route (PSAR). This ruling went into effect January 1, 2022. Provisional authorizations for COVID-19 tests that have been issued prior to this date are invalid.

To check whether a COVID-19 test kit has received full-fledged registration with the HSA, see the Singapore Medical Device Register (SMDR). The SMDR can be accessed here.

For tests not yet registered on SMDR, and for which 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 be authorized under the PSAR. Prior to authorizing, HSA evaluates to determine if these tests meet the essential standards of safety, quality and efficacy.

HSA authorizes which types of institutions can receive COVID-19 tests for professional use

The HSA released a list of COVID-19 diagnostic tests approved for professional use under the PSAR. These tests shall only be supplied to healthcare institutions, private hospitals, medical clinics or clinical laboratories licensed under the Private Hospitals and Medical Clinics Act 1980 (PHMC) Act (Cap. 248) for use on their patients.

Related Singapore medical device regulatory resources from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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