Thailand Medical Device Labeling Regulation 2025: Key Updates
Thailand’s 2025 Medical Device Labeling Regulation (B.E. 2568) sets requirements for labels and documentation of home-use, professional-use, software, reusable instruments, and accessories. Labels must include product name, intended use, batch/lot number, manufacturing/expiry dates, and manufacturer/importer info in Thai or English. Electronic documentation is allowed for software devices. Compliance is mandatory by June 20, 2026, with post-import labeling completion within 120 days.
Thailand’s Ministry of Public Health has released the 2025 Medical Device Labeling Regulation (B.E. 2568), setting new requirements for labels and documentation of home-use, professional-use, software, reusable surgical instruments, and accessories. Effective June 20, 2026, these updates clarify language, format, and content requirements to improve safety and regulatory compliance. Manufacturers and importers must review these changes to ensure smooth market access and avoid penalties under Thai medical device law.
Key Updates in Thailand Medical Device Labeling Regulation 2025
New definitions for home-use and professional-use devices
Mandatory Thai language for home-use devices; Thai or English for professional-use
Specific label and documentation rules for:
Software or application-based medical devices (UDI for Class 2–4)
Reusable surgical and dental instruments
Accessories
Labeling and Documentation Requirements
Mandatory Label Content
Product name, intended use, quantity, batch/lot number, manufacturing/expiry dates
Manufacturer/importer details and license or notification number
Labels must be clear, legible, and non-misleading
For imported devices, labels at customs must include at least five (5) key topics
Medical Device Documentation
User manuals or package inserts must include:
Product details and operation principles
Intended use, indications, instructions
Contact info, storage, warnings
If info already appears on the label, documentation may be exempted
Documentation may be paper or electronic (QR code, website)
Compliance Timeline
Post-import, complete labels/documentation within 120 days (previously 180 days)
Ensure alignment with device classification (home-use vs professional-use)
Early updates prevent delays or market access issues
Comparison: 2020 vs 2025 Regulations
Feature
2020
2025 (New)
General label topics
12
9
Documentation
Home-use & Professional-use separate
Unified 9 topics
Software devices
Not specific
UDI required (if available)
Reusable instruments
Not specific
Detailed labeling rules
Accessories
Not specified
Mandatory labeling
Import labels
180 days
120 days; explanation allowed if info missing
Steps for Manufacturers and Importers
Review product classification (home-use vs professional-use)
Update labels and package inserts with required content
Implement electronic documentation for software devices
Ensure customs labels are compliant at import
Train staff and communicate deadlines to stakeholders
Internal Links
External Links
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