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The Thai Food and Drug Administration (FDA) has officially announced the rates for expenses related to monitoring, auditing, and surveillance activities aimed at ensuring compliance with medical device regulations. This new fee structure, effective from November 13 2024, addresses expenses for document evaluation, testing, facility inspections, and related activities to control the manufacturing, importation, and

The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging. Key Highlights of the Draft Announcement: Revocation of

Regulatory updates, Thailand On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use. The key points of the guidelines are as follows: 1. Labeling

On October 4, 2024, Thai FDA released an announcement in their website about processes involving approved license. The Thai FDA defines the following: Refer: For the process that requires referring the approved dossier of medical devices to new dossiers with changes new name for the medical device (Change of Brand Name). Transfer: For the process

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

Last September 30, 2024, the Thai FDA Facebook page shared an infographic on how to classify wound dressing products according to the Thai Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). Related stakeholders shall consider the criteria when determining whether or not wound dressing products can

On October 2, 2024, the Thai FDA published an infographic on its official website about the Renewal, Termination, and Non-Renewal of five (5) Thai FDA Licenses applicable for local importers and manufacturers. The steps to be taken are as follows: Download the forms from the Medical Device Control Division’s website. Register for an OPEN ID