Regulatory updates, Thailand
On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use.
The key points of the guidelines are as follows:
1. Labeling Requirements for Home Use Devices:
- Languages: The label must be in both Thai and English (provided by the manufacturer).
- Clarity: Both versions of the label must contain clear and legible text.
- Content: The labels must include all mandatory information as outlined in the Ministry of Public Health’s Notification on Labeling and Documentation Standards for Medical Devices, B.E. 2563 (2020).
2. Labeling Requirements for Professional Use Devices:
- Languages: The label must be in English (provided by the manufacturer).
- Clarity: The label must contain clear and legible text.
- Content: It must include all required information as specified in the Ministry of Public Health’s Notification on Labeling and Documentation Standards for Medical Devices, B.E. 2563 (2020).
3. Guidelines for Attaching Medical Device Labels:
- Label Artwork : The attached label must display the artwork of the labels, showing all sides of the packaging, from the primary label to the outer box. A single side of the label is insufficient.
- Clarity of Images: The images on the labels must be clear and legible to the naked eye.
- Multiple Package Sizes/Product Codes: If the device comes in multiple packages sizes or has various product codes, separate labels for each must be attached clearly.
- Performance or Safety Claims: If the label includes claims about performance or safety (e.g., sensitivity of 99%, accuracy of 99.99%), the Thai FDA may request supporting data for these claims.
- Additional Labels: If required by other relevant regulations, additional labels must be attached clearly to the manufacturer’s or product owner’s label.
4. Certification and Additional Requirements:
- Manufacturer/Importer Information: The label must display the name and address of the manufacturer or importer, along with the license number, notification number, or listing number (e.g., “XXXXXXXXXXX”).
- Certification Statement: A certification must be included with the following text:
- “I certify that the name and address of the manufacturer or importer will be displayed as per the current registration of the manufacturing or importing establishment.”
- “The license number, notification number, or listing number will display the 12-digit number as approved in the registration.”
- Compliance with Specific Announcements: For medical devices subject to specific regulatory announcements, labels must comply with those additional specific regulations.
- In Vitro Diagnostic Devices: Additional guidelines can be found in the Guide for Preparing Documentation for In Vitro Diagnostic Medical Devices.
5. Image Requests for New or Concerned Products:
For newly launched medical devices or devices raising concerns, the Thai FDA may request images of the actual packaging, clearly displaying the components of the test kit inside the box.
Examples of Medical Device Label Attachments:
Primary Label
Secondary Label
Required label by relevant regulations
I certify that the name and address of the manufacturer or importer will be displayed as per the current registration of the manufacturing or importing establishment.
Signature of a business operator
Effective Date:
These guidelines came into effect on October 7, 2024.
For further information, please refer to the Thai FDA’s official website: กองควบคุมเครื่องมือแพทย์ (moph.go.th).
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