Thailand’s new labeling requirements for medical devices, which include for the first time a unique device identification (UDI) requirement for software as a medical device (SaMD), take effect on June 20, 2026. The Notification of the Ministry of Public Health regarding Criteria, Methods, and Conditions on Labeling and Instructions for Use for Medical Devices 2025, which replaces a similar notification from 2020, was published in the Government Gazette on December 22, 2025.
To ensure clarity, modernity, and patient safety, the regulation requires domestic manufacturers and importers to provide labels and instructions for use (IFU) that are clearly legible, complete, and free of false or misleading claims. It also permits IFU to be provided in electronic format, such as via QR codes, websites, or other digital channels—directly relevant to SaMD, where physical labels are impractical and electronic presentation is the natural medium.
The notification distinguishes two categories for labeling language. Home-use medical devices (for lay users outside healthcare facilities) must have labels and IFU in Thai. Professional-use medical devices may display labels and documentation in either Thai or English. This distinction is significant for SaMD developers: software intended for clinical professionals may use English-language interfaces and IFU, while consumer-facing health applications must provide Thai-language content.
Labeling and UDI Requirements
Labels and IFU must include, at a minimum:
- Product name and intended purpose
- Quantity or volume
- Name and address of domestic manufacturer or importer
- Thai FDA approval number
- Lot, version, or serial number
- Manufacturing date and expiry date
For SaMD, the version number requirement is particularly relevant. The regulation also mandates display of a UDI code for SaMD in risk category 2 (moderate-risk), category 3 (moderate- to high-risk), and category 4 (high-risk), according to Thailand’s medical device risk classification system (which complies with the ASEAN Medical Device Directive and the EU Medical Device Regulation). UDI details must be displayed as part of the label.
Labels and documentation for registered SaMD complying with the 2020 notification may continue to be used for up to two years from the effective date, giving operators until approximately June 2028 to transition fully to the new labeling requirements. However, newly registered SaMD in the Thailand market must comply with this new requirement.
Looking Ahead
Companies already holding UDI codes for the US, EU, or other IMDRF-aligned markets will find the Thai compliance pathway streamlined, with the primary remaining obligation being a master data submission to the Thai FDA’s UDI database. This may present a greater challenge for SaMD developers—particularly Thai innovators—planning to launch in Thailand and other markets simultaneously.
