Overview
On June 18, 2023, Thailand announced new rules regarding the size and readability of product labels, including items made in Thailand and those imported for sale. These labels must provide key information like the product name, quantity, intended use, warnings, and expiration date. One major focus of the new rules is label readability, to ensure that consumers can easily read important details before making a purchase. For example, text must be at least 2 millimeters tall (or 1.5 millimeters for smaller labels). Labels must remain readable and proportional to the product packaging.
Labeling Requirements for Pharmaceutical Products and Medical Devices
The 2023 rules include labeling updates for specific categories of products, including medical devices and pharmaceuticals. Pharmaceutical products must have labels in Thai and include important information, including product names, active ingredients, dosage forms, strength, usage instructions, warnings, and storage conditions. Labels must follow the guidelines from the Thai Food and Drug Administration to guarantee clarity for consumers.
The Ministry of Health is in the process of updating its medical device labeling requirements. Please double check before proceeding. At the time of publication, labels must be in Thai or have a Thai translation. Using symbols and icons on medical device labels is acceptable if they are widely recognized and understood by healthcare professionals.
For Class I Medical Devices, labeling requirements include:
- Name and address of the manufacturer or authorized representative
- Device model or catalog number
- Intended use
- Date of manufacture or lot/batch number
- Clear instructions for use
- Warnings or precautions
- Information on storage conditions and shelf life, if applicable
Additional requirements for Class II, III, and IV devices are as follows:
- Detailed technical specifications and performance characteristics
- Standard operating procedure for installation, operation, and maintenance
- Description of the device’s principles of operation
- Description of contraindications and side effects, if applicable
- Precautions for use and potential risks
- Information on sterilization, if applicable
- Information on compatible accessories or components, if relevant
Labeling Requirements for Pre-packaged Food
On July 19, 2024, Notification No. 450 B.E. 2567 (2024) came into effect, introducing major updates to the labeling rules for prepackaged foods. This notification includes several important changes for food businesses, including updated definitions for terms like “Best Before” to align with international standards. It specifies exceptions to the labeling requirement such as unprocessed foods and food sold directly to consumers by manufacturers providing that information. Other topics include warning labels ingredient claims, label design, and trademarks. To help businesses with the transition, products labeled before July 19, 2024, are permitted to be sold until July 18, 2026 (two years from the notification’s effective date).