Tag Archive for: TFDA

UDI Labelling Mandatory for Certain Taiwan Medical Devices

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.

Thai FDA Issues Guidance on Specialist Review Selection Criteria

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.

Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

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