THAILAND · MEDICAL DEVICES

Thailand Medical Device Labelling Requirements 2026: What Manufacturers Need to Change

Thailand medical device labelling and Instructions for Use (IFU) requirements changed on 20 June 2026, when the updated Ministry of Public Health rules took effect.

The new framework replaces the previous 2020 labelling rules and addresses physical devices, home-use products, professional-use devices, software medical devices and electronic product information.

For manufacturers already registered in Thailand, this is not simply a registration issue. Existing label and IFU artwork should also be reviewed against the new requirements.

Home-use and professional-use devices are treated differently

The intended user determines the basic language approach. Devices intended for home use or use by the general public must provide the required label and accompanying information in Thai.

For devices intended for healthcare professionals, the required information may be provided in Thai or English, provided it is clear and understandable. Manufacturers should resolve this distinction early because it affects the localisation work needed before commercial supply.

What information should manufacturers review?

Labels and accompanying documents must clearly identify the device and support its safe use. Depending on the product, required information includes the product name, intended purpose, instructions, warnings and precautions, manufacturer or importer details, batch or serial identification, manufacturing date and expiry date or useful life.

Claims must remain consistent with the approved device information and must not be false, exaggerated or misleading. Adapting global artwork for Thailand therefore requires more than translation: check the Thai-market label and IFU against the registered intended use, device configuration and applicable user category.

Electronic IFUs are now formally recognised

The updated rules accommodate electronic delivery of accompanying information through a QR code, website or other digital channel where the applicable requirements are met.

This can help with extensive instructions or supporting information that needs updating. It does not remove the obligation to make the correct information clearly identifiable and accessible to the user. Review both the electronic IFU content and the way it is linked to the device being supplied.

Software medical devices need a different labelling approach

Software and applications may not have conventional physical packaging, so their labels and accompanying information need to be available in a form appropriate to the product.

Thai FDA’s software guidance specifically highlights web applications, downloadable files, CD-ROM and USB delivery formats. Where software is supplied with physical packaging, that packaging should also be checked for applicable label information.

For software as a medical device (SaMD), consider how users reach the label and IFU within the product experience, rather than automatically copying the artwork structure used for a physical device.

Existing products have a transition period

The requirements became effective on 20 June 2026. According to the Thai Government’s implementation announcement, qualifying labels and accompanying documents prepared under the previous requirements before that date may continue to be used for no more than two years from the effective date.

This transition is not a blanket exemption for all existing products or newly prepared artwork. Confirm whether the particular labels and documents qualify. Renewals, change notifications, new import planning and artwork revisions provide practical opportunities to align with the current framework.

Thailand medical device labelling: what to review now

Start by confirming whether the device is for home use or professional use. Compare the current label and IFU with the registered product scope, including the product name, intended purpose, models, warnings, manufacturer information and traceability details.

For electronic IFUs, check accessibility and the connection between the supplied device and the correct document. Review software devices separately, including information displayed in the software and on any physical packaging.

The aim is to ensure that the device imported and supplied in Thailand matches both its registration and the current labelling framework.

Planning a Thailand medical device registration?

MediPass supports overseas manufacturers with Thailand Medical Device Registration, labelling review, local regulatory coordination and post-registration compliance.