The Thai Food and Drug Administration (Thai FDA) is advancing its medical device regulatory system into the digital era by introducing revised application forms for establishment registration for the manufacture, import, and sale of medical devices. The updated forms are designed to be more modern and responsive to emerging technologies, particularly standalone software, with the aim of facilitating business operators, reducing procedural burdens, and enhancing consumer confidence through clearer and more transparent information.

Dr. Rungruthai Muanprasitporn, Deputy Secretary-General of the Food and Drug Administration, revealed that the Thai FDA has revised the application forms related to medical device business operations in order to align with the context of a digital society and evolving medical technologies, particularly medical devices without physical characteristics, such as diagnostic software and various medical data-processing programs. The key changes are as follows:

• Supporting new technologies: The scope has been adjusted to cover the notification of storage locations for medical devices in the form of standalone software, as appropriate.
• Clear and verifiable information: The forms now require clearer information on location, contact channels, and responsible persons overseeing the manufacture, import, or sale of medical devices.
• Reducing redundant procedures: The content of the forms has been streamlined, with unnecessary sections removed to enhance business efficiency.

In this regard, the Thai FDA has issued three notifications in B.E. 2569 (2026) to support these changes, covering the manufacture, import, and sale of medical devices, with the aim of ensuring uniform standards nationwide.

Dr. Rungruthai added that the revision of the application forms for the manufacture, import, and sale of medical devices will not only help reduce burdens and improve operational efficiency for business operators, but will also enable consumers, as well as medical and public health professionals, to access accurate information on licensed manufacturers and importers, thereby ensuring the highest level of safety in the use of medical devices in Thailand.

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Publication date 5 March 2026