Last September 30, 2024, the Thai FDA Facebook page shared an infographic on how to classify wound dressing products according to the Thai Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). Related stakeholders shall consider the criteria when determining whether or not wound dressing products can be classified as medical devices as follows:
| Wound Dressing Products | |
|---|---|
| Classified to be medical devices | Classified not to be medical devices |
| If the product meets the above specified requirements, it is classified as a medical device according to Section 4 (1) (a) and (b) of the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). | If the product meets the above specified requirements, it is not classified as a medical device according to Section 4 of the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). |
For more information, refer to the following infographic.
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