Thailand
REGULATORY AUTHORITY: Medical devices are regulated by the Thai Food and Drug Administration (FDA).

CLASSIFICATION SYSTEM: 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).

TIMEFRAME: 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.

LICENSE VALIDITY: 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. 

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: 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
 
 
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