On July 03, 2025, the Thai Food and Drug Administration (FDA) released an infographic via their official Facebook page to clarify which smartwatch functionalities fall under the classification of medical devices. This guidance is important for stakeholders involved in the production, import, and sale of smartwatches in Thailand.
To view the official infographic, refer to: FDA Thai | Nonthaburi | Facebook (Thai FDA Official Website in Thai)
Which SMARTWATCH functions are classified as Medical Devices?
Smart watch | Evaluation Result | |
Medical device | Not medical device | |
1. Embedded medial functions | ✔ | |
2. Standalone medical functions 2.1 Smart watch without medial functions | ✖ | |
2.2 Smart watch with downloaded medial functions | ✔ | |
Implications to Clients
If a smartwatch product includes features or functionalities that classify it as a medical device, it must obtain approval from the Thai FDA prior to importation and sale in Thailand. Additionally, importers and manufacturers of such products are required to comply with the medical device regulations set by the Thai FDA.
Effectivity Date: July 03, 2025
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
| Functionalities | Details of Use | Evaluation Result | Medical device | Not medical device |
|---|---|---|---|---|
| 1. Medical use for diagnosis |
| |||
| 2. General health
monitoring not considered a medical device |
| |||
| 3. Diverse Uses For medical use and health care (as per purpose of use by the manufacturer) | Measures heart rate - Medical use for diagnosis such as heart abnormality. | |||
| - For sports use as a form of exercise such as measure heart rate during exercise or play sports. | ||||
| Measures blood oxygen saturation – Medical use for diagnosis such as lungs abnormality and circulatory system | ||||
| - For sports use as a form of exercise or travelling such as hiking to check the condition of the body at that time | ||||
| 4. Disclaimer not for medical use i.e. Sport use for information only, not medical use. Currently, there is not enough academic documents or information published internationally to show that it can be used in other fields other than medical use. | – Measures blood pressure (BP), for screening or diagnosis of high blood pressure. | |||
| – Measures blood sugar (Blood Glucose), for screening or diagnosis of diabetes. | ||||
| - Measures sleep abnormalities (Sleep Apnea), screen or diagnosis and evaluate the severity of sleep apnea. | ||||
| – Measures core body temperature for screening or diagnosis. | ||||
Smart watch | Evaluation Result | |
Medical device | Not medical device | |
1. Embedded medial functions | ✔ | |
2. Standalone medical functions 2.1 Smart watch without medial functions | ✖ | |
2.2 Smart watch with downloaded medial functions | ✔ | |
Implications to Clients
If a smartwatch product includes features or functionalities that classify it as a medical device, it must obtain approval from the Thai FDA prior to importation and sale in Thailand. Additionally, importers and manufacturers of such products are required to comply with the medical device regulations set by the Thai FDA.
Effectivity Date: July 03, 2025
For more information or assistance, contact us at sales@andamanmed.com or click the button below.
