Thailand Medical Device Labeling Regulation 2025: Key Updates

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

Steps for Manufacturers and Importers

1. Review product classification (home-use vs professional-use)

2. Update labels and package inserts with required content

3. Implement electronic documentation for software devices

4. Ensure customs labels are compliant at import

5. Train staff and communicate deadlines to stakeholders

Internal Links  

• Thailand Medical Device Registration

• Thailand Medical Device Labeling

External Links

• Official Notification B.E. 2568 (2025) – Ministry of Public Health Thailand

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