Tag Archive for: TFDA

UDI Labelling Mandatory for Certain Taiwan Medical Devices

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In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.

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Thai FDA Issues Guidance on Specialist Review Selection Criteria

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Get the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.

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Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

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On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.

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