Thailand FDA to Improve Medical Device Advertising Review Times

In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated its intention to improve advertising review times. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the review and approval of advertisement applications. The proposed changes include auto-approving some Class 1 advertisement materials.

It’s important to note that these updates are not formal, and more information will be provided once official guidance and/or regulations are released. 

For more information on registering medical device advertisements in Thailand, please see our dedicated page on the topic here. 

Some Class 1 Product Advertisements May Receive Auto-Approval 

One of the significant updates is that the TFDA will begin auto-approving some Class 1 products to help clear out the application backlog. For example, the TFDA expressed the intention to auto-approve all products listed under Class 1, Rule 4 including the following product types: 

• Hospital beds 
• Wheelchairs 
• Commode chairs 
• Bath trollies 
• Emergency trollies, medical equipment table/trolley 
• Walking aids 
• Overbed tables 
• IV poles 
• Examination beds 
• Stairs 
• Cabinets 
• Stretchers 
• Electric hospital beds 
• Electric wheelchairs 
• Baby weight scales 
• Weighing scales with wheelchairs 

Asia Actual will monitor regulation updates from the TFDA and will provide updates as soon as they’re available.

Advertising Review Process

Currently, the advertising review process can be difficult and time consuming for some advertisers marketing direct to consumer. The TFDA closely reviews all advertisements to ensure the claims being made are accurate and proven.

Advertisements directed towards Healthcare Professionals (HCPs) do not need to be reviewed but do need to be submitted to an online portal prior to placing on the market.

More information on the medical device advertising requirements can be found here on our dedicated page.