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The following information is excerpted from a March 2001 Industry Sector Analysis report by the Department of Commerce's U.S. Commercial Service office in Thailand. Please contact the Medical Device Industry Desk at (202) 482-4431, or e-mail email@example.com for a copy of the complete report.
In Thailand, medical devices are regulated by the Medical Device Control Division of the Thai Food & Drug Administration (Thai FDA) under the Ministry of Public Health. To import medical devices into Thailand, an importer must apply for and receive an import authorization and registration permit from the Thai FDA prior to shipment. Thailand prohibits the import of used/refurbished medical equipment. In addition, devices that cannot be marketed or sold in the country-of-origin (as attested by a certificate of free sale, such as the U.S. Food & Drug Administration's Certificate to Foreign Government) will not receive permission to be registered in or imported into Thailand.
The Thai FDA accepts devices that meet the following jurisdictions' requirements, as demonstrated by a certificate of free sale: the United States (USFDA), European Union (CE mark), Japan (Pharmaceutical Affairs Bureau), Australia (Therapeutic Good Administration) and People's Republic of China (State Drug Administration). The authenticity of Certificates to Foreign Government must be further attested to ("consularized") by either the Thai Consulate in the U.S. (in Washington, D.C.) or the Commercial Section of the U.S. Embassy in Bangkok. While a consularized certificate of free sale is required, it is not necessarily sufficient to obtain Thai registration, depending on the risk classification of the device in question.
Classification: Thailand categorizes medical devices into three classes. U.S. exporters should note that these classes are in the reverse order as compared to the USFDA's three-tier classification system (e.g., under the Thai classification, Class 3 devices are subject to the least stringent controls, whereas in the United States, USFDA Class-III devices are those subject to the strictest controls). Firms are advised to contact the Thai FDA directly (see below) for questions regarding the classification of particular products. The Thai classification scheme is as follows:
Thai Class 1 devices require a license authorization from the Thai FDA to be imported and marketed (as well as to be manufactured locally). This class includes condoms, surgical gloves, syringes, and HIV test kits for diagnostic purposes. To obtain registration of Thai Class 1 devices, manufacturers must demonstrate compliance with Thai Industrial Standards Institute standards (based on ISO standards) and for some products, undergo testing by The Thai FDA.
Thai Class 2 devices do not need a license, but must be registered, with a declaration of the details of their physical properties, contents, production process, quality, packaging, labeling, storing, and other required information. A USFDA Certificate to Foreign Governmentor other certificate of free sale issued by an authorized agencies in the country-of-manufacture is required. Products in this class include rehabilitation devices, blood alcohol level measuring kits, silicone implants, and HIV test kits other than for diagnostic purposes.
Thai Class 3, the lowest-risk category into which most devices fall, may be imported as long as it can be demonstrated that such devices are freely marketed and sold in the manufacturing country. Again, a certificate of free sale is required.
Labeling: Medical devices sold in Thailand must be labeled in Thai. (Other languages are also allowed to appear, provided that the Thai-language labeling is equally or more prominent). Labels should include the product name, class and type; name, address and country of origin of the manufacturer as well as the importer; license number and lot number, summarized usage instructions, and expiration date, if any. Single-use devices are to be explicitly labeled as such.
Registration Process, Validity and Rights: It generally takes three months to complete the registration process. Upon granting import authorization, the Thai FDA subsequently notifies the Thai Customs Office to permit clearance of the devices upon entry into port. The product registration is valid for 2 years. The registration rights belong to the applicant, who normally is the agent or distributor for the foreign manufacturer, rather than the manufacturer itself. The Thai FDA requires that the manufacturer or its representative register in person, through a locally-based legal entity. Should a foreign manufacturer change the Thai agent/distributor within this two-year period, the new Thai representative will need to re-register the product.
Thai Food & Drug Administration Contacts:
& Drug Administration of Thailand
Device Control Division, Food & Drug Administration of Thailand
General import duty rates for selected medical device categories:
Last updated on 5-2-05 by JF
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