.png)
.png){kind=small}
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
DEVICE CLASS | FEES | TURNAROUND TIME (TAT) |
|---|---|---|
Class 1: Listing | THB 3,100 | Up to 80 days |
Class 2 & 3: Notification | THB 49,000 | 250 days |
Class 4: Licensing | THB 74,000 | 300 days |
Product Registration Routes
DEVICE CLASS | CONDITION |
|---|---|
Class 1 & Animal Medical Devices | Must acquire Certificate of Listed Medical Devices |
Classes 2 & 3 | Must acquire Certificate of Notified Medical Devices |
Class 4 | Must acquire Certificate of Licensed Medical Devices |
ROUTE | DEVICE CLASS | CONDITIONS |
|---|---|---|
Full Evaluation | Classes 2, 3 & 4 | |
Abridged Pathway | Classes 2, 3 & 4 |
-
Assessed by expert reviewer
-
Assessed by Thai FDA officers
-
Undergo Reliance Program - Must receive HSA approval
-
Assessed by Thai FDA officers
-
Approval from reference agency
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.
ต้องการรายละเอียดเพิ่มเติม?
เราอยู่ที่นี่เพื่อช่วยเหลือ ติดต่อเราได้ที่แพลตฟอร์ม ATTOPOLIS.
