Thai FDA has implemented a new framework for certain medical device advertisements, enabling automatic approval for predefined types of promotional content. This initiative aims to maintain regulatory compliance while facilitating faster, more efficient communication of product information to the market.

Effective Date: 18 July 2025.

 

Scope and Eligibility

Thai FDA has introduced 3 categories eligible for auto-approval:

• Promotional Items or Giveaways: Only advertise the product name, trademark, or company name.
• Low-Risk Medical Devices: Advertisements for devices listed as low-risk by Thai FDA.
• Label and Product Display: Show only product label, product image, standard price, and promotional offers (excluding medical services).

Compliance Requirements for Stakeholders:

• The product must have a valid Thai FDA approval.
• All advertisements must fully comply with existing Thai FDA advertising regulations.

 

Auto-Approval Process

1. Submission: Companies submit advertisement materials using the Thai FDA's specified documents and online portal.
2. Commitment: Companies must accept and certify the accuracy and authenticity of the uploaded documents
3. Payment: After completing document uploads, the advertisement license fee must be paid.
4. Activation: The system will indicate that the advertisement is valid and effective.

 

Benefits for Industry

• Faster Market Communication: Enables quicker deployment of approved advertisements.
• Reduced Administrative Burden: Simplifies approval for routine marketing materials.
• Regulatory Clarity: Clearly defines which types of content are eligible for auto-approval.

 

Conclusion

Even with auto-approval, companies remain responsible for ensuring the accuracy of all claims and must avoid misleading or exaggerated statements about product capabilities.

This auto-approval framework represents a forward-looking, risk-based system that enhances operational efficiency while ensuring compliance and protecting patient safety.

Need Assistance with Advertisement Submissions?

Our regulatory specialists can review advertisement materials, confirm eligibility for auto-approval, and guide preparation to ensure full compliance with Thai FDA 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

1. Medical Device Advertising System Guidance (Specific type-Based Approval System)
2. Thai FDA: Auto-approval for specific type of Advertisements