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January 18, 2026
Approximately 5 minutes
Thailand Notification on Labeling and Package Inserts for Medical Devices (2020)
Thailand Notification on Labeling and Package Inserts for Medical Devices (2020)
1. Legal Basis and Effective Date
The Notification of the Ministry of Public Health Re: Display of Labels and Package Inserts was issued on 22 September 2020 under the authority of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf It became effective upon publication in the Government Gazette and applies to all medical devices placed on the Thai market, whether manufactured locally or imported.
2. Purpose and Scope
The Notification aims to standardize labeling and accompanying package inserts to provide clear, accurate, and sufficient information for safe and proper use of medical devices by healthcare professionals, patients, and users. It covers labels affixed to the device, its packaging, and any insert or leaflet included in the package. https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
3. Mandatory Label Content
Labels must include at least the following information in Thai language (with optional additional languages):
- Device name or trade name
- Manufacturer’s name and address
- Importer’s name and address (for imported devices)
- Model or catalog number
- Lot number, serial number, or batch code
- Manufacturing or expiry date
- Special storage or handling conditions
- Warnings, precautions, or contraindications
- Intended use or purpose
- Symbols and abbreviations explained in accompanying materials https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
4. Package Insert Requirements
For devices requiring detailed instructions, a package insert must be provided in Thai, containing:
- Detailed description of the device
- Indications and intended use
- Contraindications, warnings, and precautions
- Instructions for use, installation, and maintenance
- Performance characteristics and limitations
- Adverse effects or potential risks
- Sterilization method (if applicable)
- Disposal instructions
- Manufacturer and importer contact information https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
5. Format, Legibility, and Placement
- Labels and inserts must be clear, indelible, and legible under normal use conditions.
- Text size must be sufficient for readability (minimum requirements specified for certain elements).
- Labels must be affixed securely in a prominent position on the device and/or primary packaging.
- For small devices or sterile packaging, minimum information may be placed on outer packaging with full details in the insert. https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
6. Special Provisions
- Custom-made devices and investigational devices have modified labeling requirements.
- Symbols may be used in accordance with international standards (e.g., ISO 15223), provided explanations are included in the insert or labeling.
- Changes to labeling require prior approval from the Thai FDA in certain cases. https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
7. Compliance and Enforcement
Non-compliance with labeling requirements may result in refusal of import, product seizure, or penalties under the Medical Devices Act. The Thai FDA conducts post-market surveillance to verify label accuracy and completeness. https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
This Notification plays an essential role in Thailand’s medical device regulatory system by ensuring users have access to critical information for safe and effective device use. https://en.fda.moph.go.th/media.php?id=482373036973105152&name=20200922%20Notification%20of%20the%20Ministry%20of%20Public%20Health%20Re%20Display%20of%20Labels%20and%20Package%20Inserts.pdf
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