Medical Device and IVD Labeling in Thailand

Medical Device and IVD Labeling Requirements in Thailand

Medical device and IVD labels and IFU must comply with the current Thai rules and remain consistent with the authorized device. The Ministry notification on labels and accompanying documents published on 22 December 2025 became effective on 20 June 2026. Review the actual imported-product and transitional conditions rather than applying a universal 180-day relabeling allowance. For import, assess at least:

• Product name

• Name and location of the manufacturing facility

• Lot number, serial number, or production batch identifier

• Manufacturing date and expiration date

The License Holder is responsible for maintaining labeling compliance throughout the product’s life cycle.

Core Labeling Elements

Map the following information to the device, packaging and accompanying documents as required by the applicable rule and product:

• Product name

• Information about the medical device such as the main component, Mechanism etc.

• Intended use or indications for use

• Quantity

• How to use

• Name and address of the manufacturer or importer

• City and country of the manufacturing facility (for imported products)

• Thai FDA registration number or license number

• Name, address, and phone number for complaints or user questions

• Lot number, serial number, or production batch identifier

• Manufacturing date and expiration date

• Storage condition

• Warning, contraindications, and precautions

Labels must be durable and visible on the product, its packaging, or both. For small devices where space is limited, labeling may be applied to the outer packaging, but essential information, such as the product name and lot number, must still be visible at the point of use.

Language and Translation Requirements

Translation requirements depend on who will use the device. For home-use devices, all labeling must be in Thai. This applies to primary packaging and the IFU. For professional-use devices, labels can be in Thai or English. Additional languages can be included, but the content must be consistent across translations.

Symbols and icons are permitted but must be accompanied by explanatory text (on the label or IFU) in Thai or English.

Instructions for Use (IFU) Requirements

IFUs are required for most devices, although content and language requirements depend on the intended user. Devices intended for home use must include a Thai-language IFU. This should explain the device’s intended purpose, operating instructions, maintenance and storage requirements, contraindications, and safety warnings. For professional-use devices, English IFUs are acceptable.

IFUs must include:

• Product name

• Information about the device, such as the main component, mechanism, etc.

• Intended use

• Quantity

• Name and address of the manufacturer or importer

• Indications, directions, and instruction for use

• Storage conditions

• Warning, contraindications, and precautions

• Month and year of issuance or latest version of IFU

Electronic IFU is conditional on the device, user and applicable rule; it is not an unrestricted alternative to paper. If an electronic IFU is used, users must be clearly directed to it, typically through a QR code, web link, or reference on the label. Separate IFU may not be required in certain low-risk cases where the product label contains all necessary information. However, this must be confirmed during the regulatory review.

Current rules, UDI and artwork release

Use Thai FDA’s final labeling notification and its supporting materials to assess effective requirements and any transition for existing products. A March 2025 consultation is not the current final rule. Assess UDI obligations through the separate Thai FDA UDI program; do not infer a universal Class 2–4 implementation deadline from the earlier draft.

Maintain a checklist recording the applicable language, required physical information, permitted electronic content, registration identifier and controlled IFU version. Reconcile the product name and manufacturer/importer details with the certificate and registration dossier. Have Thai translations checked against intended use, warnings and contraindications, then assess the change-filing implications before releasing revised stock.

For regulatory terminology and the authority framework, see the Thai FDA.