The Food and Drug Administration (Thai FDA) is advancing the modernization of its regulatory system by improving the criteria for record-keeping and reporting on the manufacture, importation, and sale of medical devices. The initiative introduces electronic data systems, reduces unnecessary reporting procedures, and retains essential information required for effective consumer protection.

 Dr. Rungruthai Muanprasitporn, Deputy Secretary-General of the Thai FDA, revealed that the Ministry of Public Health, through the Thai FDA, has issued the Notification of the Ministry of Public Health on Criteria, Procedures, and Conditions for Record-Keeping and Reporting on the Manufacture, Importation, or Sale of Medical Devices B.E. 2568 (2025). This new notification revises the previous regulation issued in 2021 in order to better align the reporting system with current public health contexts.

The revised framework aims to modernize national medical device data management while facilitating business operations. Under the new approach, only information essential for safety surveillance and effective regulatory management will be required for reporting. Key changes include the following:

   1.       Businesses may prepare records in electronic format, aligning regulatory processes with digital-era operations.

   2.       The registrant as the importer or manufacturer of licensed medical device, notified medical device , and listed medical device must submit reports only for specific categories:

      o    Annual sales reports are required solely for medical device software intended for professional medical and public health practitioners (software for professional use).

      o    Quarterly sales reports are required only for certain high-risk medical devices, including those containing mercury, radioactive substances, and 49 medical devices deemed essential in emergency situations as specified in the notification annex.

   3.       Extended reporting timeline: The deadline for submitting annual reports has been extended from 31 March to 31 May of the following year.

Dr. Rungruthai added that the updated criteria will significantly reduce administrative burdens for business operators while enabling the government to access critical information more quickly. This will strengthen post-market surveillance, improve safety monitoring, and support more effective national policy development for medical devices. The reform reflects the Thai FDA’s ongoing commitment to modernizing regulatory systems, facilitating innovation and business operations, and ensuring that consumers continue to be protected through efficient regulatory oversight.

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Publication Date 2 February 2026