: 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 February 24, 2017.
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