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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:  Medical Device Registration Exemption Criteria, Methods and Conditions  prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

THAILAND: Medical Device Registration Exemption Criteria, Methods and Conditions prior to Manufacture, Importation and Sales updated by Thai FDA– June, 2021

  • 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

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