Medical Device Classifications The Medical Device Control Division of the Thai Food and Drug Admi

Medical Device Classifications

The Medical Device Control Division of the Thai Food and Drug Administration (FDA) is responsible for the regulation of medical devices in Thailand. Medical devices in Thailand are broken down into three classes: Class I, II and III. However, unlike the U.S. Food and Drug Administration, the classifications are reversed. Class 1 medical devices are the most regulated and Class 3 medical devices are the least regulated.

Class I medical devices are called “License” medical devices because they are the only medical products requiring full registration with the Thai FDA before manufacture or sale in Thailand. For example, seven devices are listed by the Thai FDA under the Class I category. They include HIV test kits for diagnosis, insulin disposable syringes, contact lenses, examination gloves, and surgical gloves.

Class II medical devices also are clearly listed by the Thai FDA regulations. The five medical devices currently regulated as Class II products include HIV test kits for research and study, breast enhancement products, alcohol detectors, implanted silicone breast prosthesis, and physical therapy products. The Thai FDA calls this category of medical devices “Notification” medical devices because they do not require full registration, but the Thai FDA needs to be notified with the appropriate documents prior to marketing or importing.

If a medical device is not one of the products specifically mentioned in Class I or II, it will fall under Class III, regardless of risk. Because the Thai FDA provides an official list (with only a limited number of devices) of specific Class I and II medical devices, most medical devices in Thailand will be classified as Class III products. Class III medical devices are “General” medical devices and do not require full product registration in Thailand.