Thailand, 06, FEB 2026 — The Thai Ministry of Public Health has officially published the new Announcement regarding Criteria, Methods, and Conditions for Displaying Labels and Documentation for Medical Devices B.E. 2568 (2025) in the Gazette. This long-awaited update modernizes the regulatory landscape for medical device FDA labeling in Thailand, introducing distinct requirements for “Home Use” versus “Professional Use” devices and formally establishing rules for electronic labeling (e-labeling) and software. Here is what manufacturers and importers need to know to ensure compliance before the enforcement date.
THAI NEW FDA LABELING STANDARD: THE KEY CHANGES
The new regulation replaces the previous B.E. 2563 (2020) announcement and introduces several critical updates designed to improve clarity for users and flexibility for manufacturers.
1. Distinction Between “Home Use” and “Professional Use” The regulation now explicitly defines two categories of devices, with different language requirements for each:
- Home Use Medical Devices: Devices intended for lay users (non-medical professionals) or used outside of healthcare facilities. FDA Labeling guidelines and documentation for these devices must be in Thai.
- Professional Use Medical Devices: Devices intended solely for medical or public health professionals. Labeling and documentation for these can be in Thai or English.
2. Electronic Labeling (e-IFU) is Officially Permitted In a move towards digitalization, manufacturers are now permitted to provide the “Document Accompanying Medical Device” (e.g., Instructions for Use) in electronic labeling formats such as CD-ROMs, QR codes, or websites. These must be clearly indicated on the packaging.
3. Specific Rules for Software as a Medical Device (SaMD) For software, applications, or non-physical devices, the regulation mandates that FDA labeling guidelines information be displayed electronically within the software itself (e.g., on a splash screen or “About” page).
- UDI Requirement: Class 2, 3, and 4 software must specifically display the Unique Device Identification (UDI).
The “120-Day” Import Buffer To facilitate trade, importers are granted a grace period upon arrival. While basic labeling must be present at the customs checkpoint (in Thai or English) , importers have up to 120 days after customs release to ensure the full, compliant label and documentation are attached before the product is sold.
TIMELINE AND TRANSITION
- Effective Date: The announcement comes into force 180 days after its publication in the Gazette. (Expected effective date: ~June 2026).
- Grandfathering Clause: Devices with labels compliant with the previous B.E. 2563 regulation that exist prior to the enforcement date can continue to be used for up to 2 years after the new regulation takes effect.
WHAT MANUFACTURERS SHOULD DO NOW
1. Categorize Your Portfolio: Review all registered products to classify them strictly as “Home Use” or “Professional Use”.
2. Assess Translation Needs: Ensure all Home Use products have comprehensive Thai FDA labeling guidelines and manuals.
3. Implement Digital Access: For Professional Use devices, consider switching to electronic labeling IFUs (QR codes) to reduce packaging costs and paper waste.
4. Update Software Interfaces: Ensure your Software as a medical device (SaMD) products are updated to display the required regulatory information and UDI within the app interface.