The Thailand medical device market is current valued at $800 million and is quickly growing. It is expected to expand at about 8% annually over the next 5 years. Meanwhile, the Thai government continues to support a universal healthcare system. Since April 2009 to the present, the government raised the per capita healthcare expenditure budget from 2,202 baht ($74) to about 2,400 baht ($81). As Thailand continues to develop, the population’s healthcare demands are likely to increase as well.
In Thailand, the Medical Device Control Division of the Food and Drug Administration (FDA), under the Ministry of Public Health (MOPH), is responsible for ensuring the safety, quality, and efficacy of medical devices. Regulation of medical devices in Thailand is governed by the Medical Device Act, enacted in 1988.
Medical devices in Thailand are broken down into three classes: Class 1, 2, and 3. However, unlike the U.S. FDA, the classifications are reversed. Class 1 medical devices are the most regulated and Class 3 medical devices are the least regulated.
The requirements for registration of imported medical devices in Thailand depend on the classification of the device. For instance, the government requires an Import License before allowing sale of a Class 3 medical device in Thailand. Applications for Import Licenses include documents such as the Certificate of Free Sale, the Good Manufacturing Practice (GMP) certificate, and the company’s Commercial Registration.