On October 7, 2024, the Thailand Food and Drug Administration (TFDA) announced new guidelines regarding labeling requirements for In Vitro Diagnostic Medical Devices (IVD). These guidelines clarify labeling methods for both home-use and professional-use IVDs, with key points outlined below.
1. Labeling Requirements for Home-Use
- Labels must be affixed in clearly readable Thai and English (provided by the manufacturer).
- Both versions of the label must comply with the TFDA’s Notification on Medical Device Labeling and Documentation Standards, B.E. 2563 (2020).
2. Labeling Requirements for Professional-Use
- Labels must be affixed in clearly readable English (provided by the manufacturer)/
- Compliance with the TFDA’s Notification on Medical Device Labeling and Documentation Standards, B.E. 2563 (2020)
3. Guideline for Medical Device Labeling
- The attached label must show the artwork displaying all sides of the package, including from the basic label to the outer box, as one side of the label is insufficient.
- Image files must be legibly readable.
- If there are various package sizes for the device or multiple product codes, they must be labeled clearly and separately.
- If efficacy and safety information or claims (e.g., sensitivity 99%, accuracy 99.99%) are indicated on the label, the TFDA may request supporting data and information for such claims.
- If required by relevant regulations, additional labels must be prepared and clearly affixed to the labels of the manufacturer and product owner.
* The label and the manufacturing/import facility registration certificates must display the name and address of the manufacturer, and importer, along with the approved 12-digit license number.
- For medical devices subject to specific announcements, labels must be prepared that comply with the medical device labeling and documentation standards and the specific requirements applicable.
Please refer to the link below.
https://medical.fda.moph.go.th/ivd-head/label-ivd-guide
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medical.fda.moph.go.th
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