US: +1 512 898-9222
SG: +65 3138-4148
The TFDA requires advertisements directed towards the public, or Direct to Consumer, to be reviewed and approved prior to displaying. New rules outlined in Gazette Volume 138, Section 312 (English) were recently implemented in December 2021. For Direct to Consumer, or DTC, advertisements, the TFDA will want to see all final versions of the advertising material, including print, web materials (i.e., ads, blogs, landing pages), or video as part of the review process per and typically require about 30 days and US $100 to review. All application materials must be submitted as hardcopy, in person, and signed by a license holder representative or juristic person. Reviews of materials can be greatly extended if the TFDA has more questions. We’ve included some tips for your consideration to help expedite the review at the end of this document.
The license holder must submit the advertising applications in Thailand and once approved, the licenses are valid for up to 3 years.
While most ad content changes will require a new application, permitted adjustments include: location of a phone number, background color, text and image layout, the size and ratio of the company name.
Gazette Volume 137, Section 2074, published in November of 2020 announced that medical devices sold to healthcare professionals are now exempt from some previous advertising requirements in Thailand. Under the new notification, medical device manufacturers do not need advertising approval anymore if they are selling products to healthcare professionals but do need to upload their material to the FDA before using.
Per Volume 137, Section 260, advertising claims that do not include descriptions of the product’s indications, benefits, quality, standard, or any components of the origin of the device. Therefore, advertisements that only use the trade or brand name and generic messaging are exempt from seeking permission.
1. Advertising directly to healthcare professionals is exempted from advertising registration and the License Holder only needs to submit an e-submission to the Thai FDA system. Once completed, advertising directly to healthcare professionals is permitted.
The following medical devices must only be sold to hospitals or medical and healthcare professionals;
As for marketing material that do not make specific claims such as descriptions of the product’s indications, benefits, quality, standard, or any components of the origin of the device, per Volume 137, Section 260, advertising approval is not required. Furthermore, advertisements that only use the trade or brand name and generic messaging are exempt from seeking permission prior to utilizing the marketing material.
Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent advertising approvals.
Contact Asia Actual for more information on our advertising approval service.
US: +1 512 898-9222
SG: +65 3138-4148
Do medical device advertisements require approval in Thailand?
Yes, advertisements for products sold Direct to Consumer or available to the general public must submit an application for each advertisement.
Products sold directly to hospitals or healthcare professionals do not require approval. However, if the advertisement is available to the public such as on a non-gated website or social media, the advertisement will require a license.
Licenses are valid for 3 years.
How much does it cost to register my advertisement in Thailand?
It will cost about US$100 per application and up to another US$500 if a Specialist Review is needed for technical information or certain claims that require data analysis.
How long does it take to register my medical device’s advertisement in Thailand?
Most applications will take 30 to 60 days but may take longer if the TFDA has multiple rounds of inquiries.
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