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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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 PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

  • 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

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