ASEAN
THAILAND
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Market Information
Thailand’s healthcare expenditure was approximately 462.3 billion Thai baht in 2020.
Market Trend: In 2021, the majority of health insured people had universal coverage cards, accounting for around 74.5 percent of all insured people. In that same year, the total number of people who are covered by health insurance in Thailand amounted to around 67.7 million.
Thailand’s medical equipment market was estimated to be worth about 6.9 billion U.S. dollars in 2023. Projections indicated that by 2030, this figure is expected to rise to approximately 11.4 billion U.S. dollars.
In the realm of medical devices, Thailand's registration process is overseen by the Medical Device Control Division (MDCD) within the Thailand Food and Drug Administration (TFDA). Established in 1991, the MDCD holds the responsibility for upholding compliance with these specific regulations pertaining to medical devices. It is also empowered to take appropriate measures against any entity or individual found in violation of these regulations.
Medical Device Regulation
Medical Device Control Division (MDCD), under the FDA.
Classification, Fees, Timeline
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Product Registration Routes
Class 1 & Animal Medical Devices
Certificate of Listed Medical Devices
Class 2 & 3
Certificate of Notified Medical Devices
Class 4
Certificate of Licensed Medical Devices
Full Evaluation
Concise Pathway (For Class 2-4)
Recognizes reference agencies' approval.
Reliance Program (For Class 2-4 or B, C, D Medical Devices)
Relies on the approval from Health Science Authority (HSA), Singapore.
Useful Information
Validity of License: 5 years.
License transfer: No transferring of license is provided by the Thai regulations.
Importer and Distributor: Local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA's manual of medical device classification.
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