Thailand's medical device labeling regulation B.E. 2568 (2025) took effect June 20, 2026. The post-importation grace period for Thai-language labeling compliance has been reduced from 180 days to 30 days. Manufacturers who built their importation and labeling workflows under the prior notification are now out of compliance and must update those workflows immediately.
Medical device labeling in Thailand is governed by the Notification under B.E. 2568 (2025), published in the Royal Gazette on December 22, 2025, and in force from June 20, 2026. B.E. 2568 supersedes the prior labeling notification (B.E. 2563, 2020). The prior notification's 180-day post-importation grace period for Thai-language labeling compliance no longer applies. The figure of 180 days appears in older online guides and secondary regulatory sources; it is outdated and should not be relied upon for current compliance planning.
Under B.E. 2568, the grace period within which post-importation Thai-language labeling must be applied is 30 days from the date of importation. Manufacturers whose logistics and labeling workflows were designed around the 180-day window must audit and update those workflows to reflect the current requirement.
The core home-use vs. professional-use language distinction that governed labeling under B.E. 2563 is preserved under B.E. 2568. The tightening of the grace period is the primary operational change for manufacturers already on the Thai market.
Thailand's labeling framework assigns different language requirements based on whether a device is designated for home use or professional use. This designation is product-specific and is confirmed as part of the classification and registration process. It is not a determination the foreign manufacturer makes unilaterally; it follows from the device's intended use as stated in the Thai FDA submission.
Devices intended for use by lay persons in a domestic environment, without the supervision of a trained healthcare professional. Labels must be in Thai language and clearly readable. Instructions for Use (IFU) must be submitted in Thai. Application forms for home-use device submissions must also be in Thai. The 30-day post-importation compliance window applies from the date each shipment enters Thailand. Blood glucose meters, thermometers, home blood pressure monitors, and personal-use diagnostic devices are typical home-use products subject to the Thai-language labeling requirement.
Devices intended for use by trained clinical, surgical, or technical personnel in a professional healthcare setting. Labels may be in Thai or English. IFU may be in Thai or English. The professional-use designation does not exempt a device from all labeling obligations; it addresses the language requirement specifically. All other labeling content requirements under B.E. 2568 apply regardless of use category.
Manufacturers distributing the same device across both home-use and professional channels in Thailand may face different labeling requirements for different distribution streams. This should be identified and addressed at the registration stage, not at the point of import.
Instructions for Use (IFU) are a required component of medical device labeling under Thai FDA. The language requirement for IFU follows the same home-use vs. professional-use distinction as the label itself.
Must be submitted in Thai as part of the CSDT dossier. The IFU submitted to Thai FDA is the version approved for the Thai market. Post-approval changes to IFU content require a variation submission to the MDCD before the updated IFU enters the market. Thai-language IFU preparation should be built into the dossier preparation timeline, not treated as a translation task to be completed after regulatory approval.
May be in Thai or English. Where English IFU is used, it must be the version approved in the Thai FDA submission. Manufacturers should not substitute a home-market English IFU for the Thai-registered version without a variation submission if the content differs.
IFU content must be consistent with the approved intended use, the device description, and the risk management documentation submitted in the CSDT. Claims in the IFU that are not supported by the approved submission create a compliance risk at post-market inspection and at renewal. The IFU is a regulated document; it is not a marketing document.
Foreign manufacturers preparing a Thai device submission frequently ask which documents must be in Thai and which may remain in English. The answer depends on the document type and the home-use vs. professional-use designation of the device.
Labels for home-use devices. IFU for home-use devices. Application forms for home-use device submissions. These are non-negotiable requirements under B.E. 2568. Thai FDA will not accept English-language versions of these documents for home-use products.
Labels for professional-use devices. IFU for professional-use devices. CSDT technical documentation in all sections, including the clinical evidence report, risk management file, design and manufacturing information, and device description. The technical file language flexibility reflects Thailand's ASEAN harmonization commitment; CSDT technical sections are accepted in English across ASEAN member states.
Once a device is registered, any change to approved labeling or IFU requires a variation submission. Introducing a Thai-language label to replace a previously approved English label on a professional-use device, or updating Thai-language content on a home-use device, is a labeling variation. The variation must be submitted and approved before the updated labeling enters the Thai market.
The reduction from 180 days to 30 days under B.E. 2568 is not a technical compliance change; it is an operational one. The underlying labeling content requirements are largely preserved. What changed is the window within which post-importation labeling must be applied. For manufacturers who used the prior 180-day period as operational buffer, the 30-day window changes the logistics of every import shipment.
Practically, this means Thai-language labeling must be ready and available at the point of importation, not assembled after the goods clear customs. Labeling must be applied within 30 days of import. Manufacturers whose Thai labeling is produced overseas and shipped separately from the product, or whose Thai labeling is prepared by the local distributor after receipt, may not meet the 30-day window under those arrangements.
The labeling compliance obligation falls on the Thai local license holder from the date of registration approval. The license holder is responsible for ensuring that every commercial shipment entering Thailand is labeled in compliance with B.E. 2568 within the required window. Foreign manufacturers should confirm with their local holder that the holder's importation and labeling processes are updated to reflect the current regulation before the next shipment.
We prepare Thai-language labeling and IFU as part of the CSDT dossier process, not as a post-approval translation task. For home-use devices, Thai-language documentation is drafted, reviewed, and included in the submission from the outset. For professional-use devices, we advise on the language option that best supports the manufacturer's operational workflow and labeling supply chain.
We audit existing importation and labeling workflows against the B.E. 2568 30-day requirement for manufacturers already on the Thai market. For manufacturers entering Thailand for the first time, the labeling compliance structure is built into the market-entry plan before the first shipment is arranged.
Labeling variation submissions are managed as part of our ongoing license holder service. Changes to approved labeling are not informally implemented and later disclosed; they are submitted and approved before the updated labeling enters the market.