Medical Device Registration and Approval in Thailand

General country-specific regulatory information is provided on this page for medical device registration and approval in Thailand. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Thailand, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in 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.

For more information on Medical Device Registration in Thailand, check out the following article: Country at a glance: Thailand.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, Philippines, SingaporeVietnam

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