Thai FDA to Decrease Registration Application Processing Times

On January 15^th and 16^th the Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day. Likewise, the target review time for risk class 2-4 medical device application review times are being reduced from 200 days to 120 calendar days without an Expert Review; and from 250 days to 150 calendar days for applications subject to Expert Review. These changes are expected to be fully implemented in Q1 of this year.

Advertising Review Time Update

Another welcome change is that advertising approval application for certain risk class 1 medical device will be subject to automatic approval. More information on this announcement can be found here.

The advertising review process in Thailand poses challenges and consumes time, particularly for advertisers targeting direct-to-consumer markets. The TFDA scrutinizes all advertisements to verify the accuracy and substantiation of the claims made. Advertisements targeting Healthcare Professionals (HCPs) are exempt from mandatory review but must be submitted through an online portal before being placed on the market.