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June 1, 2025
Approximately 5 minutes
Thailand Medical Device Advertising Approval: Rules for DTC and HCP Communication
Thailand Medical Device Advertising Approval Requirements
The Thai Food and Drug Administration (TFDA) regulates medical device advertising based primarily on the target audience: Direct-to-Consumer (DTC) advertisements require prior approval, while those strictly targeted at Healthcare Professionals (HCPs) are subject to different rules.
📣 Advertising Direct to Consumer (DTC)
All advertising material directed toward the general public must be reviewed and approved by the TFDA prior to being displayed.
- Materials: This includes all final versions of advertising, such as print ads, web materials (ads, landing pages, blogs), and video content.
- Process: Applications are submitted by the License Holder via the e-submission portal.
- Timeline and Fees: The standard review typically takes about 30 days but can be extended if the TFDA issues inquiries. A government review fee (approx. US $100) is required.
- Validity: Once approved, the advertising license is valid for up to 3 years.
👩⚕️ Advertising to Healthcare Professionals (HCP)
Advertisements sold directly to hospitals or strictly targeting Healthcare Professionals (HCPs) are generally exempted from the prior advertising approval requirement.
- Exemption Condition: Manufacturers must submit the advertising material to the Thai FDA system via e-submission before using it. No full registration or approval is required.
- Public Access Restriction: If a professional-use medical device advertisement is visible to the public (e.g., on an ungated website), a full advertising registration is required. To maintain the exemption, access must be restricted, often requiring HCPs to sign in or provide their medical license number.
Devices Requiring Restricted Sale
Certain medical devices, due to their nature, must only be sold to hospitals or medical/healthcare professionals. Advertisements for these products must strictly restrict public access. Examples include:
- Ophthalmic Viscosurgical Devices (OVD)
- Silicone breast implants
- Injective Hyaluronic for defective skin
- HIV test kits (excluding self-test kits)
🚫 Exempt Marketing Material
Marketing materials that do not make specific claims about the product's indications, benefits, quality, standards, or origin are generally exempt from seeking permission. This includes advertisements that use only the trade or brand name and generic messaging.
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