Importing Medical Devices to Thailand: The Basics

The Thai market for healthcare products grew an estimated 12 percent last year. The next few years should see similar or even greater growth. With heart disease and cancer the two major causes of death in Thailand, and increasing numbers of Thais reporting respiratory ailments (caused largely by Thailand’s rampant air pollution), products in these areas potentially have high sales in Thailand. Such products include, but are not limited to, heart valves, stents, and artificial blood vessels; respiratory devices; oxygen generators; and guidewires.

The Medical Devices Control Division of Thailand’s Ministry of Public Health controls the import of medical devices. The government classifies medical devices as follows: Class 1 devices, which include condoms, surgical gloves, and syringes, need a license from the Thai FDA to be manufactured, imported, and marketed in Thailand. Class 2 devices, which include rehabilitation devices, blood alcohol level measuring kits, and silicone implants, do not require a license, but do need to be registered. Finally, Class 3 devices, which include most medical products, must only be freely marketed and sold in the manufacturing country to be approved for import. A “Certificate of Free Sale,” issued by the U.S. FDA, a local Chamber of Commerce, or similar organization is also required to register Class 2 and 3 products before importing. Thailand will not accept any devices that are not approved in the country of origin.