Instructions for Use (IFU) Requirements in Thailand

1. Key takeaways

Whether instructions for use must be in Thai depends on the use scenario. For home-use devices, the IFU must be in Thai and must be submitted as part of the CSDT dossier. For professional-use devices, the IFU may be in Thai or in English, but the English IFU must be the version approved in the Thai submission; it cannot be replaced by the English version used in the manufacturer’s home market, and any difference in content requires a change application. Under B.E. 2568 (2025), the IFU must contain the product name, a detailed description, the use, contraindications, directions for use, contact details for enquiries and complaints, storage method, warnings and precautions, and the document version or latest revision date, together with the device description, the instructions for use except where use is self-evident, the names and addresses of the producer or actual manufacturer and the importer, contact details unless already given on the label, storage conditions, and the contraindications, warnings and precautions.

• Home-use devices: IFU in Thai, submitted as part of the CSDT dossier.
• Professional-use devices: IFU in Thai or English, with the English IFU being the version approved in the Thai submission; differing content requires a variation.
• Where items 1-3, 5-6, 8 and 12-13 are already clearly stated on the label, a separate IFU need not be attached.
• Electronic IFU is permitted: the instructions may be paper or electronic form, such as CD-ROM, QR code, or website link, under paragraph 4 of Article 6, but must still carry all the required information, and some high-risk products may still be required to provide a paper IFU.
• Software and apps: the label and instructions must be presented in electronic form and must include the version number and the UDI where applicable.
• IFU content changes are possible but require prior approval: the submitted version is the approved version for the Thai market, and content changes must go to the MDCD as a variation, with the new version marketable only after approval.

2. Legal basis

The requirements come from the MoPH labelling notification B.E. 2568 (2025). Article 6 and its paragraph 4 govern the content of the instructions for use and recognise the electronic IFU, which may be delivered as paper, CD-ROM, QR code or website link. The notification also lists the mandatory contents of the IFU, a set of fourteen items, including the product name, detailed description, use, contraindications, directions for use, contact details for enquiries and complaints, storage method, warnings and precautions, and the document version or latest revision date, along with the device description covering main components, working principle and type or kind, the instructions for use except for devices whose use is self-evident, the names and addresses of the producer or actual manufacturer and of the importer, contact details unless already provided on the label, storage conditions, and the contraindications, warnings and precautions. Where items 1-3, 5-6, 8 and 12-13 are already clearly listed on the label, the IFU may be omitted. For software and apps, the label and instructions must be in electronic form and include the version number and the UDI where applicable. IFU changes must be filed with the MDCD as a variation and approved before the new version may be marketed, and the responsibility for label compliance rests with the registrant, the licence holder, and is not transferred by entrusting an importer or distributor.

3. Expert insights

The point most often missed is version control. The IFU version submitted is the version approved for the Thai market, and updating the IFU overseas and simply rolling the new version out in Thailand constitutes an unapproved change, a violation that surfaces during inspections rather than at submission. The professional remedy is to manage the Thai IFU as a controlled document: build a register recording the approved Thai IFU version number, its effective date, and the differences against the global version, and check that register every time the global IFU is updated; if the Thai version is affected, file the variation with the MDCD and let approval precede release. The second insight concerns the electronic IFU. Paragraph 4 of Article 6 makes e-IFU an explicit cost-reduction path for products with lengthy or frequently updated instructions, since a QR code or website link can carry the full required content, which must remain complete: the product name, detailed description, use, contraindications, directions for use, contact details for enquiries and complaints, storage method, warnings and precautions, and the document version or latest revision date. But the path is not universal, because some high-risk products may still be required to provide a paper IFU. Finally, note who owns the obligation: label compliance responsibility belongs to the registrant, the licence holder, and does not shift to an entrusted importer or distributor.

4. Practical recommendations

• Bring IFU version management into the post-market compliance system with a register of the approved Thai IFU version number, the effective date, and the differences against the global version.
• Compare the Thai version against every global IFU update and file a variation with the MDCD whenever the Thai version is affected; release the new version only after approval.
• Confirm the language regime per product: Thai IFU for home-use devices submitted within the CSDT, and for professional-use devices a Thai or English IFU that matches the approved submission exactly.
• Assemble the IFU against the mandatory content list of B.E. 2568 (2025), and apply the labelling exemption where items 1-3, 5-6, 8 and 12-13 are already clearly stated on the label.
• For software and apps, prepare the electronic-form label and instructions with the version number and the UDI where applicable.
• Where an e-IFU is used, verify that all required information is included in the electronic delivery, and confirm whether the product class still requires a paper IFU.

5. Verification checklist

• □ Verification basis date: 26 October 2026.
• □ MoPH labelling notification B.E. 2568 (2025), Article 6 and paragraph 4, recognising the e-IFU.
• □ Home-use and professional-use IFU language requirements.
• □ The mandatory IFU content list of fourteen items and the exemption rule where the label already states the items.
• □ Electronic-form IFU for software and apps, with version number and UDI requirements.
• □ IFU changes filed with the MDCD as a variation before marketing.
• □ Label compliance responsibility 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