Medical devices may not be promoted or advertised to healthcare professionals or institutions in Thailand without permission from appropriate regulatory authorities, according to a directive issued in November by the country’s Food and Drug Authority.
The guidelines on direct advertising were among several new requirements published by the Thai FDA on direct advertising and labeling of medical devices.
The guidelines permit direct advertising of medical devices to providers via print, video, digital, and telephone. But potential advertisers are required to provide a variety of information to regulators first, including the regulatory status of the medical device or devices, the type, and content of the advertisements, and signed certification that all information in the advertisement is verifiable and complete.
The labeling requirements are similarly stringent. They mandate that all statements on labels be accurate and correct and prohibit the inclusion of misleading claims. Labels must detail the name, description, purpose, and method of use of the device. In addition, labels must include licensing and manufacturing facility information, serial number, safety warning, and a raft of other standard cautions and product details.