Translated with AI

The regulatory framework for medical device labelling in Thailand reached a comprehensive synthesis with the publication of the Medical Device Labeling Regulation (B.E. 2568) in the Royal Gazette on December 22, 2025. Regulation B.E. 2568 strictly clarifies and defines the objectives and requirements for labelling (labels and accompanying documents), consolidating previously fragmented provisions into a single framework and introducing key operational updates, particularly regarding reusable devices, language requirements, and the use of digital media.

The deadline for mandatory compliance has been set for June 20, 2026.

For manufacturers, this represents a transition from a system often subject to varying interpretations to a framework of clearer, more defined requirements for content, language, and timelines, within the broader scope defined by the Medical Device Act B.E. 2551 (2008) and its subsequent amendments.

The new framework

Regulation B.E. 2568 focuses on three fundamental pillars:

• Transparency and Safety (Articles 5-8)
  The regulation specifies the minimum content for labels and instructions, with a particular focus on reusable devices (Chapter 2), for which it is mandatory to detail sterilization cycles and storage conditions to ensure post-market safety. For reusable devices, including surgical and dental instruments, the Regulation requires clear indications of sterilization cycles, storage conditions, and, where applicable, post-opening shelf-life; for other devices, such information is mandatory only if relevant to the product.

  While requirements apply to all device classes, the Thai FDA tends to scrutinize high-risk products (e.g., implants, critical SaMD) more closely to ensure consistency between the label, IFU, and the registration application.

• Language Requirements (Article 10)
  The distinction between home-use and professional-use devices is now codified. For home-use products, labels and IFUs must be strictly in the Thai language to protect non-expert users. For professional-use devices, the use of English remains valid, provided it is clear and accessible to clinical personnel.

• Digitalization (Articles 12-14)
  The Regulation officially authorizes the use of QR codes and e-IFUs, particularly for software (SaMD) and connected devices. For certain high-risk devices, the Thai FDA may still require a paper IFU; thus, the choice between digital and physical media must be evaluated on a case-by-case basis. Digital information must be synchronized with physical documentation, updated in parallel with any registration changes, and accessible offline to ensure information continuity in any clinical context.

The 120-Day Post-Import Requirement

A critical point for the supply chain is Article 15, which governs the post-import phase. Once a license is obtained, the importer has a mandatory 120-day deadline to complete compliant labelling in Thailand, including language management, QR codes, and layout. Exceeding this window carries the risk of a distribution block in the local market, with potential repercussions on supply lead times.

Compliance Checklist: Mandatory Content (Ref. B.E. 2568)

Based on the consolidated requirements, every device must ensure the presence of the following data, where applicable and according to Thai FDA instructions (on the primary label and/or accompanying documentation):

• Identification: Trade name and intended use.
• Traceability: Batch/serial number and UDI code (where applicable).
• Company Data: Name and address of the manufacturer and the local importer.
• Timelines: Date of manufacture and expiration (or post-opening stability).
• Instructions: Warnings, contraindications, and precautions for use.
• Technical Management: Storage conditions and validated sterilization procedures.

How to Prepare for the Deadline

Taking immediate action on product portfolio classification (home-use vs. professional, risk class) is essential, as classification directly influences language requirements, IFU type, and mandatory labelling content. Updating graphic layouts and clearly defining responsibilities between the manufacturer and the local importer, specifically regarding in-country labelling and compliance with the 120-day limit, are fundamental steps for a smooth transition.

The 2026 Thai market no longer accepts uncertainty: labelling compliance is now the central pillar of patient safety and a key element for commercial sustainability in the country.

>>> Thema supports you in complying with all product requirements for the Thai market. We assist you through every regulatory phase to ensure a solid and seamless commercial presence.

SOURCE: กองควบคุมเครื่องมือแพทย์

Publication date: 29/01/2026