General country-specific regulatory information is provided on this page for medical device registration and approval in Thailand.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical Device Control Division (MDCD) of Thai Food and Drug Administration (TFDA) working under Ministry of Public Health.
CLASSIFICATION SYSTEM:
Medical Devices and IVDs:
TIMEFRAME:
SPECIAL REQUIREMENTS
On-Site Audit: on-site audit only required for a novel medical device that require a technological assessment.
Local Tests/Permit: In-country local testing is only required for HIV-related test kit.
Local Clinical Evaluation or Studies: Not applicable
LOCAL FEES (New Application)
LOCAL FEES (Manufacturer): The establishment who wishes to import medical devices to Thailand shall apply for a medical device Importing Establishment License. Any establishment who wish to sell licensed medical device shall apply for a License to Sell.
LICENSE VALIDITY: 5 years
LICENSE TRANSFER: License transfer would not be necessary as the foreign manufacturer can have more than one license holder for the same product. However, any changes (including change of the name of license holder) must be notified to the Thai FDA.
AUTHORIZED REPRESENTATIVE: The foreign manufacturer should appoint a company located in Thailand to become their representative.
Last updated on April 20, 2021.
For more information on Medical Device Registration in Thailand, check out the following article: Country at a glance: Thailand.
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