Regulatory Updates

On September 20, 2024, Thai FDA released the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer, or other cases of medical devices that have previously been approved and not required academic documents evaluation by experts, government

To ensure that the control measure of medical devices is appropriate to the current situation and in line with the development of medical technology, it is expedient to cancel the announcements from the Ministry of Public Health related to medical devices for the detection of SARS-CoV-2 (COVID-19). Therefore, the Minister

The Thai Food and Drug Administration Office (TFDA) has adjusted control measures for the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) detection to align with the risk levels of medical devices. The previous requirements for technology assessment and related standards for manufacturers or importers of COVID-19 test kits

The Thai Food and Drug Administration (FDA) issued an infographic regarding the guideline for registration of notified medical device for diagnostic test kits and reagents for SARS-CoV-2 (COVID-19). The infographic (in Thai) can be accessed here. The main idea of this infographic is referred from the Ministry of Public Health