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.
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.