Under the Medical Device Act of 2008, companies with registered medical devices (business operators) must prepare and submit reports about malfunctions experienced by medical devices to the Thai Food and Drug Administration (FDA) concerning devices they manufacture, import, sell, or where the use of devices have caused adverse events. The business operators must also report any corrective actions taken after the adverse event, even if the event occurred outside of Thailand. Though these requirements are part of the Medical Device Act of 2008, the Ministry of Public Health Notification only published the criteria, methods, and conditions for submitting these reports recently, which came into effect on November 4, 2016. Criminal fines or imprisonment terms may be imposed upon business operators who fail to comply.
The notification is meant to monitor the safety and usage of medical devices, similar to a system used to monitor pharmaceutical productions. These new standards are in line with ASEAN and Western international standards. Additionally, the notification will allow the Thai FDA to appropriately manage medical device risks in order to ensure consumer and public health safety.