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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

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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THAILAND: Thai FDA Notification on Licenses Renewal Guideline – November,2021

THAILAND: Thai FDA Notification on Licenses Renewal Guideline – November,2021

  • 2021-11-24 09:26:58

As we approach the end of the year, Thai FDA published a renewal guideline for licensed and notified medical device manufacturing and importation licenses that will be expired on 31 December 2021. To continue to engage in their respective activities, manufacturers and importers shall comply with this guideline within 1st October to 31st December 2021.

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THAILAND:  Latest Regulation on Medical Device Labeling – August 2021

THAILAND: Latest Regulation on Medical Device Labeling – August 2021

  • 2021-08-26 12:49:31

Thai FDA alerted Medical Device Establishment concerning labeling and device document implementation applicable for all 4 classifications; Licensed Medical Device (Class 4), Notified Medical Device (Class 3+2), and Listing (Class 1). This remarkable movement is aiming to ensure consumer safety while practicing device traceability during post-market surveillance.

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