The FDA has opened "Fast Track" channel for changes notifications for manufacturers of essential medical devices who face unavoidable supply chain disruptions in raw materials and packaging materials.
These changes notifications can be reviewed more rapidly by officials than standard change notification, to support manufacturers during the crisis.
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.
了解更多 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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