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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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THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

  • 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

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MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

  • 2022-12-27 05:48:52

The Malaysia Medical Device Authority (MDA) released the latest 4th Edition Change Notification for Registered Medical Device, MDA/GD/0020. More substantial changes were made compared to the 3rd Edition. There are new additional clauses and updated documents requirements. The MDA revised the turn-around time for Category 2 and Category 3. Furthermore, some changes do not require a change notifications to be submitted to MDA.

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MALAYSIA: MDA Announced the New Guidance on Requirements for Labelling of Medical Devices – December 2022/January 2023

MALAYSIA: MDA Announced the New Guidance on Requirements for Labelling of Medical Devices – December 2022/January 2023

  • 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

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