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​ 

March 9, 2026
Over the past several years, numerous automobile manufacturers have brought electric vehicles (EVs) to the market and received positive feedback from consumers in Thailand and around the world. EVs have gained popularity due to their lower maintenance costs, reduced energy expenses, and environmental benefits. However, reports have emerged of EVs causing problems such as battery fires, autopilot malfunctions leading to accidents, and safety systems such as brakes engaging automatically under inappropriate conditions. Even when these situations do not cause injury to drivers or passengers, they raise significant concerns for EV manufacturers, importers, and sellers operating in Thailand. These problems may seriously impact businesses if the products are identified as unsafe under Thailand’s Product Liability Act (PLA), officially known as the Liability for Damages Arising from Unsafe Products Act. Under this law, authorities or courts can order business operators to recall products from the market or prohibit their export, import, or sale. To manage and mitigate the risk of being found liable for damages due to an unsafe product under the PLA, EV business operators should be aware of the scope of the law. Potentially Liable Parties The PLA identifies several types of entrepreneurs and business operators—both individuals and entities—as “potentially liable parties” (PLPs) who may be held liable under the law. In the EV context, this could include vehicle manufacturers, battery suppliers, software developers whose systems are integrated into the vehicle, and local importers or distributors. Specifically, the PLA covers: Manufacturers or hirers Importers Sellers of goods for which the manufacturer, hirer, or importer cannot be identified Any other party who uses the name, trade name, trademark, or statements associated with the alleged unsafe products, or acts in a manner that causes them to be perceived as a manufacturer, hirer, or importer Definition of “Product” and “Unsafe Product” The
Read More
February 26, 2026
Laos’ Food and Drug Department (FDD) has been using a new online registration system for drugs since the beginning of the year. The system, which was implemented following the November 2025 issuance of Notice No. 5960/FDD, became the official pathway for submissions on January 1, 2026. Since that date, paper-based registrations have no longer been accepted. This marks a significant advancement in the digitalization of regulatory processes in Laos. As the online system is now the exclusive platform for registration, renewal, and amendments, companies that have not yet aligned their processes to the new system should act promptly to ensure a smooth transition. To assist with this, the FDD will conduct periodic training sessions on the use of the online registration system, which will be delivered either in person or remotely, depending on operator demand. To start using the system, drug and medical device manufacturers, as well as import-export companies, that have not yet registered must submit a formal request identifying the authorized personnel who will access the platform, after which they will be issued user accounts and access codes. Each request must be accompanied by the company’s enterprise registration certificate (incorporation certificate), a copy of the identity card or passport of each designated user, and a scanned copy of their signature. There is no restriction on the number of users per company, allowing flexibility to meet operational needs. Companies that already hold accounts and access codes from the trial phase may continue using them and may apply for additional accounts if needed. Additional Requirements The new system also introduces a standardized format for drug registration numbers. For example, an import drug registration number such as 06 I 4040/15 will be changed to 06-IM-04040-15, and a domestic drug registration number such as 06 L 4040/15 will be changed to
Read More
January 21, 2026
Spurred by global geopolitics and Canada’s Indo-Pacific Strategy, which aims to forge deeper ties with ASEAN, Canadian companies have been showing growing interest in Thailand and Southeast Asia in recent years. To understand the opportunities offered by the region, we sat down with Andrew Stoutley, a Toronto native and the chief operating officer of Tilleke & Gibbins, a leading Southeast Asian regional law firm with over 130 years of history in Thailand. Q: Why are Canadian companies looking at Thailand and Southeast Asia right now? A: Two reasons stand out. First, diversification has moved up the agenda. Many Canadian companies want options outside North America due to tariff volatility and policy uncertainty in the United States, as well as questions around the next Canada–United States–Mexico Agreement mandatory joint review. At the same time, the shift of global production from China to Southeast Asia is accelerating, driven by rising costs, geopolitics, and the need to avoid overreliance on a single market. As a result, Canadian companies are looking for a second production base or a regional hub, and Thailand and its neighbors are natural choices given their manufacturing depth, location, and established supply chains. Second, Canada’s own efforts in the region are gaining traction. The Indo-Pacific Strategy has led to more on-the-ground support, including larger trade missions, upgraded diplomatic posts, and new financing options. Export Development Canada (EDC) now has a presence in Bangkok, giving Canadian companies a direct line to financing and insurance in Thailand. There’s also steady progress on trade frameworks like the recently signed Canada–Indonesia Comprehensive Economic Partnership Agreement (which will come into effect pending domestic procedures), ongoing negotiations of a Canada–ASEAN FTA, and the exciting announcement about the launch of negotiations of a Canada–Thailand FTA. Together, these developments have the potential to make it much easier
Read More
January 8, 2026
Thailand’s approach to cannabis regulation has moved quickly from broad access to a medical, prescription‑only system. The latest government regulation classifies the cannabis flower as a controlled herb under the Thai Traditional Medicine Wisdom Act. The latest rules ban advertising and recreational sales, allow sales only to patients with prescriptions (up to 30 days), and require flowers to come from GACP‑certified (Good Agricultural and Collection Practices) farms. More importantly, cannabis dispensaries can only sell to patients presenting valid prescriptions issued by one of seven professions—medical doctors, Thai traditional practitioners, applied Thai traditional practitioners, traditional Chinese medicine practitioners, pharmacists, dentists, and folk healers—consistent with approved clinical indications. Noncompliance risks license suspension or revocation, and criminal penalties of up to one year’s imprisonment or a THB 20,000 fine. The dispensary‑only model that proliferated in Thailand in recent years is expected to end soon, as the rules will push all cannabis dispensaries into medical settings or retail pharmacies. Dispensaries must convert into medical establishments—clinics, pharmacies, or traditional pharmacies—complete with on‑site licensed practitioners as well as budtenders; strong controls for storage, hygiene, odor, and smoke; and facilities for record-keeping. All flowers dispensed or exported must come from GACP‑certified farms. If the government ends dispensaries outright and forces a conversion to clinics or pharmacies, compensation will not be automatic at the outset. As a result, business operators should plan for compliance and repurposing under the Medical Facilities Act, Modern Drug Act, and Herbal Product Act, which regulate medical clinics, modern pharmacies, and traditional medicine pharmacies, respectively. The table below summarizes the required licenses for clinics, pharmacies, and traditional medicine pharmacies selling cannabis flowers in Thailand. Aside from the specific listed licenses, all three types of establishments must also obtain a license to sell a controlled herb (cannabis flowers) from the Department of Thai Traditional
Read More