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: Medical devices are regulated by the Thai Food and Drug Administration (FDA).
Devices are classified into the following classes: Class I (Licensed Medical Devices, Highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).
The approval process after file submission takes about eight to ten months for Class I devices, six to eight months for Class II devices up to ten days for Class III devices.
For Class I and Class II medical devices, the product license is valid for five years. For Class III devices, it depends on the validity of the Certificate of Free Sale.
An authorized representative is required.
The Thai FDA plans to re-classify medical devices based on the level of associated risk to comply with the ASEAN Medical Device Directive.
Last updated on January 22, 2018.
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For more information on registration in Thailand, check out the following articles on our blog:
Country at a Glance: Thailand