Regulatory Affairs Update: Thailand

Thailand: FDA Infographic Announced the Format Change of Consent Form for the Reliance Program

On October 3, 2024, the Thai FDA announced updates to the consent form used for the Reliance Program. In the updated version, it is no longer necessary to include the reference number for the application submission to the Thai Food and Drug Administration. Applicants can now prepare the consent form and submit it along with the application without needing to wait for the application number or for Thai FDA officials to open a section for attachment afterward. Detailed changes to the consent form can be viewed in the table below:

Updates to form format

This change simplifies the submission process, allowing businesses to proceed more efficiently by eliminating the need to wait for administrative steps related to the reference number. This update reflects an effort to streamline procedures within the Reliance Program, providing faster and more flexible options for companies engaged in submitting medical device applications. This announcement is effective starting October 3, 2024.

For more information, refer to กองควบคุมเครื่องมือแพทย์ (moph.go.th).

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