This article breaks down the latest regulatory changes, including new criteria for obtaining an advertising license and stricter rules for revoking licenses in cases of false advertising or misuse.
Update on Advertising License Registration
Effective from January 4, 2025, Thai FDA Announcement - Guidelines, Procedures, and Conditions for Advertising License Applications, Issuance, and Validity for Medical Devices B.E. 2567 (2024) introduces:
✅ Stricter oversight on medical device advertisements.
✅ Prohibition of misleading claims that could harm consumers.
✅ Simplified procedures by removing unnecessary details.
Advertisements related to the benefits, quality, standards, and components of medical devices are only permitted if the products are listed, notified, or licensed with the Thai FDA.
Key Provisions of the Advertising License Process
- Advertising License Application
- Who needs a license? Any individual or entity intending to advertise a medical device must obtain an advertising license from the Thai FDA.
- Amendments: Any modifications to the approved advertising details require prior approval.
- Prohibited Advertising Claims
Medical device advertisements must not:
⛔ Contain false or misleading claims regarding the benefits, quality, quantity, standards, components, or origin of medical devices.
⛔Use the following terms and expressions: Best, excellent, special, miraculous, perfect, completely cured, worry-free, instantaneous, sacred, the safest, No. 1, the best, definitely, superior, no worries, confident, opportunities like this don’t come often, no allergic reactions, no side effects, including any images conveying such meanings.
⛔ Include unfair statements that mislead consumers or contradict Thai cultural norms.
⛔ Feature comparisons that disparage competitors (unless based on objective, non-branded academic studies).
⛔Contain endorsements/testimonials suggesting unproven medical benefits.
⛔Encourage excessive or inappropriate use of medical devices.
- Principles for Medical Device Advertising
- Alignment with Approved Information – Advertisements must match the product registration details approved by the Thai FDA.
- Restricted Advertising for Professional-Use Devices – If a medical device is designated for healthcare facilities or professionals, advertising to the public is allowed only if consumers play a role in decision-making.
- Mandatory Advertisement Content:
- Device Name
- Advertiser’s Contact Information (except for giveaways)
- Advertising License Number (except for giveaways)
- Product Approval Certificate Number (except for giveaways)
- Required warnings, contraindications, and precautions:
- Public-facing ads must state: “Notice the warnings on the label and accompanying documents before use.”
- Healthcare professional ads must state: “Advertise to Healthcare Professionals and Health Officials.”
- Warnings may be displayed electronically via QR codes or other digital formats.
License Validity & Target Audience Compliance
- License validity – Up to three years or as specified on the approval certificate.
- Target Audience & Approved Communication Channels:
- Advertisements must align with the intended audience and use approved communication channels.
- The advertising license must specify whether the target audience is the general public or healthcare professionals.
- Termination occurs if:
- The product license is significantly modified, rendering the advertising details invalid.
- The product license is revoked, leading to automatic cancellation of the advertising license.
Revocation of Advertising Licenses for False Advertising or Misuse
Thai FDA, in collaboration with the Medical Council of Thailand and the Department of Health Service Support (DHSS), is enforcing strict penalties for non-compliance.
- Immediate suspension of advertisements found in violation.
- Legal action against offenders to ensure consumer safety.
- Proactive monitoring of dermal filler advertisements, which are often misused beyond approved indications.
The Thai FDA encourages consumers to verify approved dermal filler products via the official Thai FDA website, where the list is updated every Thursday.
Additionally, Thai FDA and DHSS are conducting on-site inspections of healthcare facilities found violating advertising regulations.
The Director of the Medical Device Control Division emphasized that consumers with safety concerns or those who encounter illegal products can report violations or file complaints through the following channels:
- Thai FDA Hotline: 1556
- Line: @FDAThai
- Facebook: FDAThai
- Email: 1556@fda.moph.go.th
- Provincial public health offices
Conclusion
The updated Thai FDA advertising regulations provide greater clarity and ensure that medical device advertisements remain truthful and responsible.
✅ Manufacturers and distributors must comply with the new regulations to avoid penalties.
✅ Consumers should verify medical devices before purchasing to ensure safety.
If you need assistance with navigating the updated advertising license process, our team is ready to guide you through the regulatory requirements.
Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.
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References:
- Thai FDA Press Release: Thai FDA Revises Medical Device Advertising Rules to Streamline Licensing and Enhance Consumer Safety
- Thai FDA Announcement - Guidelines, Procedures, and Conditions for Advertising License Applications, Issuance, and Validity for Medical Devices B.E. 2567 (2024)
- Thai FDA: Basic Information For Advertising Medical Device
- Thai FDA Press Release: Thai FDA Cracks Down on Unauthorized Medical Device Advertisements with Immediate Suspension