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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THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

• 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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