MDR: MDCG 2022-14 - Transition to the MDR and IVDR - Notified Body Capacity and Availability of Medical Devices and IVDs – October/November 2022

• 2022-10-25 06:47:43

MDCG 2022-14 is aimed to propose solutions to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

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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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THAILAND: New Medical Devices Registration Guidance for Licensed Medical Device, Notified Medical Device and Listing

• 2021-03-22 03:45:47

Thai FDA has announced the official medical device registration guidance for Licensed medical device and Notified medical device and Listing after promptly complete a transition from policy-based classification to risk-based classification of medical devices.

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