Thailand’s Food and Drug Administration (FDA) has recently implemented a new law, Medical Device Act B.E. 2551, to replace Medical Device Act B.E. 2531. This new Act details regulations and requirements for product registration, advertisements, and punishments for non-compliance.
The Act defines and prohibits fake, unsafe, and nonstandard medical devices. Such devices include products non-compliant with applicable standards, devices with the wrong product names or company names, and products without appropriate labeling (especially those containing hazardous substances). The new regulation also clarifies which medical devices can only be sold to infirmaries or medical professionals.
Other details in the new Act include product registration processes and registration of business dealing with medical devices. There are also specific qualifications for personnel authorized to sell and distribute medical devices.
Medical companies will have to comply with advertising regulations and cannot put false or exaggerated claims on promotional materials. All products must be correctly labeled with information such as life span, warnings, and instructions for use. Again, any false or exaggerated statements are not allowed.
To ensure compliance with the new regulations, the Act also establishes a Medical Device Board. This Board will consist of individuals from various government organizations, such as the Ministry of Public Health and the Department of Medical Service.
The Medical Device Board can punish any violators of the new Act by suspending their business licenses or product registration licenses. Also, manufacturers may be required to compensate for any injuries or deaths caused by defective medical devices.
The new regulation also sets up a process for appeals against some license suspensions.
For product registration dossier, the Thai FDA is currently planning to adopt the ASEAN Common Submission Dossier Template (CSDT), as reported in the Asia Medical eNewsletter Volume 6, Number 9 (December 2006).