One of the obligations imposed on persons who have registered their medical devices under the Medical Device Act of 2008 (Business Operators) is to prepare and submit reports on any malfunctions related to the medical device products which they manufacture, import or sell, or where the use of such medical devices have caused adverse events for consumers, to the Thai Food and Drug Administration (FDA).
The Business Operators are also obligated to report the corrective actions which they have taken in relation to such events, irrespective of whether such events occur within or outside of Thailand.
However, the Ministry of Public Health's Notification to provide the criteria, methods and conditions for preparing and submitting the above-mentioned reports was only recently published in the Royal Government Gazette and will come into effect on 4 November 2016 (Notification).
Amongst the matters which are covered, the Notification includes the risk levels which would trigger the reporting obligations and the deadlines for submitting such reports.
Business Operators who fail to comply with the Notification may be subject to criminal fines and/or imprisonment terms.
The purpose of the Notification appears to be the provision of a safety monitoring program relating to the use of medical devices which is similar to what is already required for the pharmaceutical sector, and which is in line with ASEAN and other international standards.
It is hoped that the Notification will now allow the FDA to effectively monitor the use of medical device products in the Thai market and appropriately manage the risks associated with the use of such medical device products, in order to better protect the safety of consumers and public health in general.