The Thai Food and Drug Administration (Thai FDA) organized a training session to enhance the capabilities of entrepreneurs in preparing the documentation required for medical device registration using the Full Common Submission Dossier Template (Full CSDT). This template applies to medical devices with similar characteristics across ASEAN countries, aiming to reduce the steps and time needed for approval, enabling faster decision-making. Over 300 medical device manufacturers and importers participated in the training.

Dr. Rungruthai Muanprasitporn, Deputy Secretary-General of the Thai FDA, explained that the Thai FDA has a policy of promoting and supporting entrepreneurs to efficiently register their products. This involves ensuring the proper preparation of complete and accurate documents. It was noted that some entrepreneurs still lack knowledge and understanding of the necessary documents required for submission. Therefore, the training was organized to enhance knowledge and preparedness for medical device registration, specifically for in vitro diagnostic (IVD) devices, and to provide guidance on submitting requests in compliance with laws and regulations.

The Deputy Secretary-General further stated that the Thai medical device industry, including production, import, and export, is continuously growing. Enhancing the capabilities of entrepreneurs will drive the industry toward quality growth, ensuring that the public has access to safe medical devices that meet international standards, and enabling Thailand to to gain faster access medical device innovations.

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Publication Date 9 January 2026