Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019).
| Classified to be medical devices | Classified not to be medical devices |
|---|---|
| If the device has medical purposes, such as | If the device has relaxation or entertainment purposes it will "not qualify" under the definition of a medical device and, therefore, 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). |
| the product will "qualify" as the intended use specifically for treating, alleviating, or curing human injuries by the manufacturer or product owner. Therefore, it is classified as a medical device according to Section 4 (1) (b) of the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). |
Further information can be accessed at กองควบคุมเครื่องมือแพทย์ (moph.go.th) (in Thai).
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