Regulatory affairs update Thailand

Thailand: Announcement From Thailand FDA Regarding CSDT Applications, Annual Report Submission And Breathalyzers

Thailand FDA released several announcements related with the medical devices, as follows:

1. Deadline for submitting documents in Full CSDT

As of 15 February 2024 onwards, anyone who wishes to submit license applications (for Class 4 or Class D) or notification applications (for Class 2 & 3 or Class B & C)  to produce or import medical devices must submit a complete set of Full CSDT documents, as specified in the Ministerial Regulation on the Request for license and Issuance of a License to Produce or Import Medical Devices B.E. 2563 and the Ministerial Regulation on the Notification and Issuance of Notification license for the Production or Import of Medical Devices B.E. 2563.Partial CSDT submission will only be accepted until 14 February 2024. Below is the flyer posted by the Thai Authority.

2. Submission of Annual Reports for Production, Import, and Sale of Medical Devices

The Medical Devices Control Division has opened the system for submitting annual reports on the production, import, and sale of medical devices from January 1, 2024, to March 31, 2024.

Below is the flyer posted by the Medical Devices Control Division with a QR code:

3. Reclassification of Breathalyzers

In a recent regulatory update, the Thai Food and Drug Administration (TFDA) reclassified the breathalyzers, removing them from the category of medical devices. This change is expected to facilitate the use by Nightspot of using breathalyzers to screen customers before they return home, for safety reasons. These devices, however, are still effective in detecting alcohol, so the public could still be assured of the functionality of these devices. Below is the flyer posted by the TFDA:

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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