• 2022-02-18 09:04:53

Health Sciences Authority (HSA) issued a list of COVID – 19 test kits that are authorized for professional use. These kits have been given authorization under the Pandemic Special Access Route (PSAR) because Professional Use Only (PUO) kits have been designated as “emergency medical devices”.

• 2021-11-24 09:49:19

With the continuing pandemic, PFDA relaxes its regulation for the manufacture of medical oxygen and the expiry of the special certifications for imported COVID-19 test kits. However, certain conditions must be met to be eligible for these exemption or extension.

• 2021-05-22 04:20:30

PFDA shared the updated procedure for the issuance of special certification for COVID-19 test kits following recent guidance for minimum performance requirements of different types of COVID-19 Test Kits.

• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.