Newsletter

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

  • 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

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SINGAPORE: HSA Publishes Regulatory Guidelines for Laboratory Developed Tests (LDTs) – January/February 2023

SINGAPORE: HSA Publishes Regulatory Guidelines for Laboratory Developed Tests (LDTs) – January/February 2023

  • 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

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MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

  • 2021-12-27 06:04:00

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

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MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

  • 2021-11-24 10:12:53

In collaboration with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP), the controls for the expansion of self-test kit sales will be implemented. The Covid-19 self-test kit can only be purchased from licensed community pharmacies and authorized health facilities.

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