Thailand Medical Device Labelling under B.E. 2568 (2025)

1. Key takeaways

The current Thai labelling regulation is the Ministry of Public Health Notification on Criteria, Procedures and Conditions for Medical Device Labels and Accompanying Documents B.E. 2568 (2025). It was signed on 27 November 2025, published in the Royal Gazette on 22 December 2025, and enters into force on 20 June 2026, replacing the previous B.E. 2563 (2020) rules. The changes with the widest operational impact are two: the language requirements now depend on the use scenario, and the grace period for applying Thai labels after import has been shortened from 180 days to 120 days. Existing labels approved under the 2020 rules may continue in use until 20 June 2028, two years after the entry into force, but the 180-day window of the old rules no longer applies, and older guidance or secondary sources that still cite that figure must not be relied on.

• Home-use devices: labels and instructions for use must be in Thai and clearly legible, and the declaration forms for home-use devices must also be in Thai.
• Professional-use devices: labels and instructions for use may be in Thai or English.
• The home-use versus professional-use determination is product-specific, confirmed at the classification and registration stage, and is not decided unilaterally by the manufacturer.
• The grace period for applying Thai-language labels after import is now 120 days, counted from the date of import, not from clearance completion or shelf placement; the former 180-day window no longer applies.
• Labels approved under the 2020 rules remain usable until 20 June 2028, two years after entry into force.
• Class 2/3/4 devices must bear the UDI where a UDI exists, while batch numbers, dates and similar information may use English or common symbols.

2. Legal basis

The governing instrument is the MoPH Notification on Criteria, Procedures and Conditions for Medical Device Labels and Accompanying Documents B.E. 2568 (2025), signed 2025-11-27, published in the Royal Gazette 2025-12-22, in force 2026-06-20, replacing B.E. 2563 (2020). Under Article 6 of the new rules, the label on the device itself or its packaging must contain: the product name; the use or indications, which may be placed in the instructions for use when label space is insufficient; the quantity or pack size; the manufacturer or importer information, with imported products required to state both the country of origin and the importer information; the licence number or registration number; the batch number or serial number; the production date for products without an expiry date, or the expiry date for products that have one; and the method of calculating the expiry date, where applicable. This article is a dynamic page: labelling details and enforcement interpretation are subject to the current publications of the Thai FDA and the MoPH. Three categories are excluded from the new rules: devices governed by dedicated notifications, such as contact lenses, HA fillers and blood bags; devices exempted under Article 27 of the Medical Device Act; and devices manufactured or imported solely for export.

3. Expert insights

The two headline changes reward different planning habits. The language rules turn on the home-use versus professional-use determination, and because that determination is confirmed at the classification and registration stage rather than left to the manufacturer, teams should know which regime their product falls into before the artwork is designed, not after. The grace period change is the one that bites operations: the window for applying Thai labels after import is now 120 days from the date of import, down from 180 days, and the countdown starts at import, not at clearance completion or at shelf placement. Logistics procedures that still encode the old number will produce compliant-looking plans that are actually out of compliance, and the reduction is significant enough to affect supply chain designs that relied on late labelling in country. Equally important is the transition right: labels approved under the 2020 rules may continue in use until 20 June 2028, but the 180-day window of the old rules no longer applies, and secondary sources still citing the old figure must be discarded. A full SKU label audit, screening each product through language, the eight required elements and UDI, and the 2020 grandfathering question, converts a scattered set of deadlines into one managed plan.

4. Practical recommendations

• Run a full SKU label health check across three dimensions: home use or professional use, which decides the language and the language of the declaration forms; whether the eight required label elements are complete and whether the UDI is marked for Class 2/3/4; and whether existing labels qualify for continued use under B.E. 2563 until 20 June 2028.
• Write the 120-day post-import Thai labelling grace period into the logistics SOP, and state expressly that it is counted from the date of import.
• Remove the 180-day figure from all internal guidance and checklists, since the old window no longer applies and outdated sources must not be relied on.
• Confirm the home-use or professional-use determination for each product at classification and registration, and design label artwork for the applicable language regime.
• Check each SKU against the exclusion categories: dedicated notifications such as contact lenses, HA fillers and blood bags, the Article 27 exemption under the Medical Device Act, and manufacture or import solely for export.
• Track the entry-into-force date of 20 June 2026 and the grandfathering end date of 20 June 2028 in the compliance calendar.

5. Verification checklist

• □ Verification basis date: 26 October 2026.
• □ MoPH Notification on Criteria, Procedures and Conditions for Medical Device Labels and Accompanying Documents B.E. 2568 (2025), signed 2025-11-27, published in the Royal Gazette 2025-12-22, in force 2026-06-20, replacing B.E. 2563 (2020).
• □ Home-use and professional-use language requirement provisions.
• □ Grace period for post-import Thai labelling shortened from 180 days to 120 days.
• □ Labels under the old rules usable until 2028-06-20.
• □ The eight label elements and the UDI provisions.
• □ Excluded products: devices under dedicated notifications, the Article 27 exemption, and manufacture or import solely for export.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com