Tag Archive for: TFDA

Software as a Medical Device in Thailand

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On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand.

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Thai FDA Regulatory Documentation Exemptions

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March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.

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Thai FDA Reduces Application Review Time

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On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.

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Thai FDA QMS Updates to Affect GDP, GMP, and GCP

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Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.

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Thailand FDA to Decrease Registration Application Processing Times

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The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.

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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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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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Thai FDA Drafting New Guidance for SaMD and AI Device Registration

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Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.

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Thai FDA Improves Medical Device Application Process

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In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Standing out was the new Regulatory Applicant (RA) program which provides expedited reviews to applications submitted by certified RA’s and the possibility of utilizing External Expert Bodies as an additional review resource.

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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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