Advertising Direct to Consumer
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.
Permitted Adjustments and Updates
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.
Advertising to Healthcare Professionals
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.
Requirements for Advertising to Healthcare Professionals
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.
2. Public advertising, such as on a website.
If professional use medical device advertising can be seen by anyone including non-healthcare professionals, advertising registration is required. However, access to the ad must be restricted if the product is on the above list of medical devices that must be sold to hospitals or healthcare professionals. For example, before accessing the website, healthcare professionals must sign in or fill their medical license number.
The following medical devices must only be sold to hospitals or medical and healthcare professionals;
- Ophthalmic Viscosurgical Devices (OVD)
- Teeth whitening devices
- HIV test kits, excluding HIV self-test kits
- Injective Hyaluronic for defective skin
- Silicone breast implants
- COVID test kits and reagents for the diagnosis of SARS-CoV-2 (COVID-19 pathogen) infection, only with the antibody or antigen test
Products that Do Not Require Registration
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.
Come Grow With Us
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.
Thai FDA Drafting New Guidance for SaMD and AI Device RegistrationSeptember 18, 2023 - 7:14 pm
