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

The surge in AI development has led to a desperate demand for large, high-quality training data. However, real-world data can be expensive to collect, difficult to access, and often subject to strict privacy and regulatory constraints. Synthetic data, which consists of artificially generated records that replicate the statistical properties of real-world data without reproducing specific individuals’ information, provides an appealing solution by generating artificial datasets at scale without relying on identifiable personal information. It combines speed, cost efficiency, and regulatory compliance, making it a sensible alternative for organizations seeking to reduce risks while maintaining data utility. When properly anonymized, synthetic datasets may fall outside the scope of laws such as the EU’s General Data Protection Regulation (GDPR) or Thailand’s Personal Data Protection Act (PDPA), reducing compliance burdens while still supporting high-quality model training. However, relying on synthetic data without rigorous legal due diligence could be a strategic mistake. It replaces one set of known risks (scraping, direct privacy liability) with a new set of complex liabilities. The narrative that synthetic data is a “silver bullet” for privacy and IP compliance is dangerous and could be misleading. While synthetic data addresses data scarcity, it also introduces new legal uncertainties. Legal counsel should anticipate downstream risks arising from compromised data sources. Models trained on unlawfully obtained data may need to be decommissioned, even if their outputs appear lawful. What is synthetic data? Synthetic data refers to artificially generated information created using AI techniques such as deep learning and generative models. Instead of copying real records, it reproduces the statistical patterns and relationships found in the original dataset. Synthetic data generally falls into three categories: Fully synthetic data – Entirely new data points generated from learned patterns. The model studies the structure of the original data and produces records that resemble real-world

Thailand’s Electronic Transactions Development Agency (ETDA) has released a revised draft Electronic Transactions Act (ETA) for public hearing from May 12, 2026, to June 15, 2026. This is not merely an amendment to certain provisions of the current ETA, but a comprehensive redrafting of the entire act. The revised draft ETA introduces several significant changes from the current framework, with practical implications for businesses operating in Thailand. Unified Coverage of Public and Private Sectors The current law segregates government transactions into a separate chapter with distinct rules. The draft ETA eliminates this division, defining “transaction” to encompass civil and commercial juristic acts as well as administrative procedures, administrative contracts, and other acts of government agencies. Enhanced E-Signature Definition The definition of “electronic signature” is broadened to expressly include biometric data and refocused on identifying the signatory and demonstrating intent regarding the content of the electronic data. Shift in Burden of Proof When a party challenges the reliability of electronic data created using a “trusted electronic method” or a method prescribed by the ETDA, the burden of proof and the cost of proving unreliability shifts to the challenger. Introduction of New Digital Method Concepts The draft ETA introduces several new digital method concepts that are not currently recognized under the existing ETA framework. These include: Electronic timestamping (e-timestamp) Electronic registered delivery Electronic company seals Electronic stamp duty compliance Electronic identity authentication and verification Electronic transferable records (electronic bills of lading, promissory notes, and similar negotiable instruments) Recognition of Automated Systems and Electronic Contracting The draft ETA expressly recognizes the legal validity and enforceability of contracts formed through automated systems, including contracts concluded entirely between automated systems or between an automated system and a person. A party may not deny the binding effect of such contracts solely because no human review

On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.