Labelling Inspection and B.E. 2568 Requirements in Thailand

Labelling is the most visible and most easily evidenced item in a Thai site inspection. This page sets out the five focus points of a labelling inspection under the MoPH labelling notification B.E. 2568 (2025), how long previously approved labels remain usable, which products are excluded from the new rules, what happens when labels do not match reality, and the end-to-end workload of a relabelling programme.

1. Key takeaways

This is a dynamic page: inspection criteria and enforcement details are subject to pending verification against the current publications of the Thai FDA and the MoPH. Yes, the Thai FDA inspects device labelling, and it is the most direct and easiest item to evidence in a site inspection. From 20 June 2026, the inspection basis switches to the MoPH labelling notification B.E. 2568 (2025), which replaces the notification B.E. 2563 (2020). The inspection concentrates on five points: language matched to the use scenario, completeness of the eight required elements, UDI marking, the 120-day affixing grace period, and whether changes to instructions for use have been approved before release.

• Language. Labels and instructions for use of home-use devices must be in Thai and clearly legible; professional-use devices may use Thai or English. The home-use or professional-use characterisation is product-specific and is confirmed at the classification and registration stage.
• Eight elements. Product name; use or indications; quantity or package specification; manufacturer or importer information, with imported products required to state the country of origin as well as the importer; licence number or registration number; batch number or serial number; manufacturing date or expiry date; and the method of calculating the expiry date.
• UDI. Class 2, 3 and 4 devices must bear UDI marking where a UDI exists.
• Grace period. The grace period for affixing Thai-language labels after import has been shortened from 180 days to 120 days, counted from the date of import.
• Change control. Changes to instructions for use must be submitted to the MDCD for approval before the new version may be placed on the market.
• Transition. Labels approved under the 2020 rules, B.E. 2563, may continue in use until 20 June 2028.

2. Legal basis

The inspection basis from 20 June 2026 is the MoPH labelling notification B.E. 2568 (2025), which replaces the notification B.E. 2563 (2020). The notification sets out the eight required elements in its Article 6 and the provisions on electronic instructions for use in its paragraph 4, together with the language requirements distinguishing home-use devices, which must carry Thai labels and Thai instructions for use, from professional-use devices, which may use Thai or English. The affixing grace period for labels applied after import is 120 days, counted from the date of import, shortened from the previous 180 days. Labels approved under the 2020 rules may continue in use until 20 June 2028, two years after the entry into force of B.E. 2568, but this transition applies to already approved labels, and the affixing action for newly imported goods must still comply with the 120-day window. Software and app-based electronic labelling must meet the electronic labelling and version number requirements. 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; and devices manufactured or imported solely for export.

3. Expert insights

A label that does not match reality is a violation that can trigger corrective action, suspension of circulation and even recall. Beyond that direct exposure, a label inconsistent with the registered dossier is also discovered incidentally at two other checkpoints: in advertising compliance, where advertising content must match the approved intended use and labelling, and in import verification, where the LPI is checked model by model. Labelling therefore functions as the connective tissue between the registration, the marketing materials and the customs process, which is why discrepancies on a physical label tend to cascade across all three.

Responsibility for labelling compliance rests with the registrant, the licence holder, and is not transferred because the importer or distributor was entrusted with the work. This mirrors the general Thai pattern of concentrated responsibility: outsourcing the physical affixing does not outsource the accountability, so the licence holder must supervise the affixing process even when third parties perform it.

4. Practical recommendations

• Run a full-SKU label health check and produce a table recording, for every SKU: the home-use or professional-use characterisation, whether the Thai version is complete, whether the eight required elements are present, whether UDI is marked, whether the current label conforms to B.E. 2563, which determines whether it can be used until 20 June 2028, and whether the affixing process can be completed within 120 days.
• Use the same table as the basis for negotiating with packaging suppliers and for requesting budget from management, since it quantifies the work per SKU.
• Plan for the full end-to-end timeline of artwork revision, translation review, Thai FDA review where necessary, and printing of new packaging, which usually requires three to five months; companies that have not yet started face a realistic risk of missing the effective date.
• Verify the home-use or professional-use characterisation for each SKU against the product-specific determination made at the classification and registration stage, and align the label language accordingly.
• Build the MDCD change application into the artwork change process, since instructions for use changes require approval before the new version reaches the market.

5. Verification checklist

• □ Confirm the MoPH labelling notification B.E. 2568 (2025), Article 6 on the eight required elements and paragraph 4 on electronic instructions for use.
• □ Confirm the language requirements for home-use and professional-use devices.
• □ Confirm the affixing grace period change from 180 days to 120 days, counted from the date of import.
• □ Confirm that labels approved under the old rules may be used until 20 June 2028.
• □ Confirm the UDI marking requirement for Class 2, 3 and 4 devices.
• □ Confirm the electronic labelling and version number requirements for software and apps.
• □ Confirm that changes to instructions for use require prior approval from the MDCD.
• □ Confirm the excluded products: devices under dedicated notifications, devices exempted under Article 27, and devices manufactured or imported solely for export.
• □ Confirm that labelling responsibility is not transferred by entrustment.

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