There are several issues that foreign manufacturers will want to keep in mind in navigating the regulatory process in Thailand.
First, in order to import medical devices into Thailand, an importer must first apply for and receive an import authorization and registration permit from the Thai FDA. It takes three to six months to complete the registration process, and registrations are valid for 2 years. The Thai FDA requires registration in person, through a locally based legal entity. The applicant is generally the manufacturer’s agent or distributor rather than the manufacturer itself. Because of this, foreign manufacturers should always have a buyback clause in their distribution agreements to facilitate changing distributors in the future.
Classification of medical devices in Thailand can also be confusing. The most important thing to remember, especially for U.S. exporters, is that Thailand’s three-tier classification system is in reverse order of that of the U.S. FDA. In the U.S., Class I is the least restrictive and Class III the most. In Thailand, Class III is the least restrictive and Class I is the most. For those products classified in Thailand as Class I, a license authorization from the Thai FDA must be obtained before products can be imported (or manufactured locally). For registration of some Class I products, Thai FDA testing may be required, and all Class I device manufacturers must prove their compliance with Thai Industrial Standards Institute standards (similar to ISO standards). The importation of Class II and Class III devices are less stringent.
Finally, labeling instructions are fairly explicit and must be followed exactly. All devices must be labeled in Thai. Other language labeling is permissible, but the Thai labeling must be as prominent or more prominent than any other language. Labels must include: product name, class, type; the name, address, and country of the manufacturer and the importer; license number, lot number, usage instructions, and (if applicable) expiration date.
The Medical Device Control Division of the Thai Food & Drug Administration, under the Ministry of Public Health, is responsible for the regulation of medical devices in Thailand. The Director is Mr. Boonlert Kongkamee. The Thai FDA and the Medical Device Control Division can be reached at: Tivanont Road; Muang, Nonthaburi 11000; Thailand; Phone: 662-591-8479; Fax: 662-591-8480.