You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

June 17, 2026

Thailand Introduces UDI Labeling Requirements for Software as a Medical Device

Subscribe to Updates

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.

Related Professionals

Industries

Consumer Products

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

July 27, 2026
Vietnam’s new E-Commerce Law, which took effect on 1 July 2026 along with its implementing Decree No. 248/2026/ND-CP (Decree 248), marks a significant development in the country’s approach to online intellectual property (IP) enforcement, reflecting a clear shift from a reactive model of intermediary liability to one that expects platforms to play a more active role in preventing infringement. From notice-and-takedown to platform responsibility The most significant change introduced by the E-Commerce Law is the transformation of the legal role of e-commerce platforms. The existing safe harbor provisions under the IP Law and the copyright notice-and-takedown regime established by Decree 17/2023/ND-CP (Decree 17) largely required intermediaries to act only after receiving notice of infringement. Once infringing content had been removed, the platform’s legal obligation was generally considered fulfilled. The new legislation adopts a fundamentally different approach. Article 17 of the E-Commerce Law requires intermediary platforms to screen information relating to goods and services before publication in order to prevent listings involving counterfeit or IP-infringing goods, and goods of unknown origin. Rather than relying exclusively on complaints from rights holders, platforms are now expected to implement preventive measures before infringing listings become publicly available. Decree 248 further requires platforms to update keyword filters based on recommendations issued by competent authorities. These filtering mechanisms are intended to prevent prohibited listings from appearing on the platform and represent a further move away from a purely complaint-driven enforcement model. The legislation also introduces Vietnam’s first statutory stay-down obligation. Under the E-Commerce Law and Decree 248, major digital platforms must maintain automated systems capable of reviewing, warning against, and removing unlawful listings while also implementing measures to prevent repeat violations, defined under Decree 248 as conduct that has previously been identified and handled by the platform, but continues to recur. This obligation addresses one
Read More
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
Read More
July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
Read More
July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
Read More