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

Thailand has prescribed more stringent labeling specifications for traditional and electric vehicles (EVs), requiring manufacturers and importers for sale to display clear, accurate product information on vehicle labels. The requirements, which took effect on March 21, 2026, are set out in a notification issued under Thailand’s consumer protection framework. Background and Scope Under Thailand’s Consumer Protection Act (CPA), products manufactured for sale or imported into Thailand must generally comply with the CPA’s broad labeling requirements, unless the Label Committee prescribes more specific and stringent requirements for certain products. Accordingly, prior to the issuance of this notification, traditional autos and EVs were subject only to the general labeling requirements. Following the issuance of this Label Committee notification, traditional autos and EVs are now for the first time specifically subject to a dedicated regulatory framework for labeling. The requirements apply to private passenger vehicles and private trucks that have not yet been registered, including those powered by an internal combustion engine, electric power, or a combination of both. Label Requirements Labels must be displayed in Thai or with a Thai translation, and must be clearly visible and legible. Text must be proportional to the label area, with a minimum character height of 2 millimeters. All covered vehicles must display the following: Product name, trade name, or trademark Brand and model Manufacturer or importer information Size, weight, and load-bearing capacity Warranty conditions Drive system, usage instructions, and safety precautions Manufacturing date Price Additional Requirements for EVs EVs must also display the following: Type of electric vehicle (e.g., HEV, PHEV, BEV, or FCEV) Maximum electric motor power and rated continuous output power Battery type and capacity Battery warranty conditions or a clear statement that no warranty is provided Estimated driving range per full battery charge Electrical system safety standard Electricity consumption rate These

Thailand’s rise as a regional hub for luxury retail has influenced how market entry is structured and assessed across Southeast Asia. As brands consider establishing a presence in the market, regulatory and operational considerations form a key part of the overall entry assessment. Foreign Ownership Restrictions for Retailers Foreign investment in retail activities is subject to a relatively extensive regulatory framework, particularly in relation to foreign ownership and the approvals required under the Foreign Business Act B.E. 2542 (1999) (FBA). Under the FBA, a company is generally regarded as foreign if 50% or more of its shares are held by non-Thai nationals, in which case the business is required to obtain a foreign business license (FBL) issued by the director-general of the Department of Business Development, with the approval of the Foreign Business Committee. The committee will not grant an FBL unless it is convinced the proposed business demonstrates unique characteristics such as a distinctive business model, innovative processes, specialized services or products, or a clear competitive differentiation that will benefit Thailand; constitutes a highly specialized business or requires specialized technology or expertise; and will not compete with Thai business operators who engage in the same business. The committee makes its decisions on a case-by-case basis depending on the circumstances, which can make the licensing process less predictable in practice. However, there are also alternative pathways for consideration, including exemptions in specific circumstances. For example, foreign-owned businesses in Thailand with at least THB 100 million in registered capital are allowed to open five retail stores in the country. Some businesses may also be able to access preferential treatment under international agreements and treaties between Thailand and certain foreign states, subject to eligibility requirements. Structural and Business Model Challenges The determination of what constitutes a “retail store” may itself present

Thailand has liberalized its wine import regime, allowing, for the first time, multiple importers to bring in and distribute the same wine brands. On March 27, 2026, the Ministry of Finance issued the Ministerial Regulation on the Importation of Alcoholic Beverages (No. 3) 2026, which waives the requirement to appoint a sole authorized agent for alcoholic beverages to be specified in notifications from the Excise Department. The Excise Department has already issued its first such notification, expressly exempting wine and sparkling wine made from grapes from the sole agent requirement. For all other types of alcoholic beverages (e.g., beer, tequila, spirits) the sole agent requirement remains in force, and applicants for importer licenses must provide evidence of exclusive distributorship issued by the manufacturer or brand owner. The exemption may be extended to other alcoholic beverage categories through future Excise Department notifications. Implications for Competition and Tourism The reform allows multiple importers to bring in and distribute the same wine brand without routing through the brand owner’s designated exclusive importer, reducing monopolization and boosting competition. Excise Department Director-General Pornchai Thirawet noted that wine was chosen as the starting point because implementation is straightforward in this case and because domestic wine prices remain high—with increased competition expected to exert downward pressure on prices. More broadly, the reform is intended to lower market entry barriers, expand supply, and make wine more accessible to Thai consumers, while supporting Thailand’s position as a regional tourism hub. Product Quality Control and Loss of Sole Agent Accountability Under the previous framework, the designated importer bore full responsibility for the proper storage, handling, and distribution of wine and sparkling wine from importation to final sale. This arrangement helped ensure that products were maintained under appropriate conditions, including temperature control, light exposure, and humidity management, to preserve quality