Licenses to sell medical devices in Thailand will be more difficult to obtain under a rigorous new system of regulations issued in February by the Food and Drug Administration of the Southeast Asian country.
The new rules are in line with the ASEAN Medical Device Directive (AMDD), in which the ten member states of the Southeast Asian economic union agreed to implement common standards on licensing requirements, approvals, complaint channels, and fines for non-compliance of medical devices.
Thailand had already been partially in compliance with the directive, but these new regulations conform much more closely with AMDD guidelines — and will significantly expand the regulatory burden for manufacturers of medical devices.
Under the new regulations, full technical data will be required for approval of all medical devices. Previously, such data was required only for devices classified as the highest risk. The data must be submitted in the Common Submission Dossier Template format, and application fees will rise across the board.
It is also important to note that there will be new regulations on the labeling requirements of a medical device on October 31, 2021. Until then, the importer is obliged to provide the label/package insert containing the information prescribed in the Ministerial Notification.