The Deputy Government Spokesperson revealed that the FDA has issued three new announcements to elevate the regulation of production, import, and sale of "medical devices" into a digital system, effective 1 May 2026.
On 25 April 2026, Ms. Lalida Pertwiwatana, Deputy Spokesperson of the Office of the Prime Minister, stated that the Food and Drug Administration (FDA) has issued updates to the criteria and forms related to medical device establishments in three announcements covering production, import, and sale. These were published in the Government Gazette on 2 March 2026 and will take effect from 1 May 2026 onward.
This update aims to modernize regulatory oversight in line with medical technology and enhance accuracy in inspections, with key points including:
Adding the requirement to specify GPS coordinates (Latitude–Longitude) of the establishment and storage locations.
Adding digital contact methods such as email and other online channels.
Including details of the “person in charge” directly in application forms for stricter supervision.
Accommodating standalone medical software cases where physical storage locations may not be necessary.
Furthermore, this consolidates and cancels several previous announcements into a unified system, reducing legal redundancies and facilitating easier compliance for operators.
Ms. Lalida said this update reflects the government's “Digital Regulatory” approach, leveraging technology to enhance oversight alongside supporting new medical innovations, particularly software and health technologies.
“The government is advancing regulatory modernization while ensuring public safety and fostering an environment conducive to the long-term development of the country's medical industry,” she added.
Operators are advised to prepare complete information on locations, GPS coordinates, person in charge details, and contact channels to ensure smooth application submissions under the new regulations effective 1 May 2026.