Medical Device and IVD Labeling Requirements in Thailand
Medical device and IVD label content and Instructions for Use (IFU) must be approved by Thai FDA and made available no later than 180 days after customs clearance but before the product is distributed or sold. For import, labels must at least include:
- 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
All medical devices placed on the Thai market must include the following information on the product label:
- 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
IFUs may be provided in printed or electronic form. 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.
UDI requirements in Thailand
In March 2025, Thai FDA released draft guidance update that includes new labeling requirements, particularly mandatory Unique Device Identifiers (UDI) for Class 2, 3, and 4 devices. There is a two-year transition period for devices with labels that comply with the 2020 rules. However, all other devices will be obligated to comply with the new labeling requirements as soon as the guidance is final.
