The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging.
Key Highlights of the Draft Announcement:
Revocation of Previous Announcement
- The previous FDA announcement dated November 24, 2021, concerning criteria, methods, and conditions for medical device advertising permission will be revoked once this draft is enacted.
Scope and Exemptions
- MOPH announcement dated September 22, 2020 (exemptions for certain medical device advertising characteristics).
- MOPH announcement dated August 26, 2020 (exemptions for advertisements directed solely to healthcare professionals).
- Additional MOPH announcements specifying advertising characteristics exempted from requiring permission.
Requirements for advertising licenses
- Advertisers must obtain a medical device advertising license, valid for up to three years.
- Any updates or changes to the advertising license must be formally requested and approved.
Prohibited Advertising Content
Medical device advertisements must adhere to strict content guidelines:
- Prohibited claims include exaggerated or false statements regarding benefits, quality, or safety.
- Advertisements must not contain indecent or misleading messages that conflict with Thai cultural norms.
- Comparisons with other products are limited to factual, academic contexts without mentioning specific trade names.
- Excessive praise or endorsements of a medical device’s benefits are not permitted.
- Misleading messages about a device’s substance or encouraging unnecessary usage are prohibited.
Criteria for License Approval
- Only licensed manufacturers or importers may advertise medical devices and must obtain approval for all claims.
- Medical devices intended for healthcare units or professionals may only be advertised to the public if consumer involvement is required in decision-making, as per Section 6 (10) of the Medical Device Act B.E. 2008.
Required Display Information
Advertisements must display:
- The device name, advertiser’s contact details, and advertising license number (excluding media giveaways or souvenirs).
- License, notification, or listing numbers as applicable.
- Warnings, contraindications, and precautions for general public advertisements, except on media such as giveaways or billboards.
- “Advertise to Healthcare Professional and Health Official” when targeting healthcare professionals.
Electronic Accessibility of Information
Information can be displayed electronically, such as via QR codes, to ensure accessibility.
Advertising Conditions and Validity
- Advertisements must follow permitted messaging, audience, and channels.
- Licenses remain valid for three years unless there is a significant change in the license details or if the license is revoked.
Electronic Submission and Compliance
- Applications, permissions, and related documents may be processed electronically in line with the Electronic Procedures Act.
- If electronic processing is not possible, submissions should be directed to FDA offices or provincial public health offices.
Transition for Existing Licenses
Existing medical device advertising licenses will remain valid until expiration or revocation.Prohibited Words and Claims
Advertisements must not contain terms suggesting exaggerated effects, such as “miraculous,” “safe,” “best,” or “no side effects.”
For full details, access the draft announcement here (in Thai). If you have any questions, please contact us at sales@andamanmed.com or click the button below for assistance with compliance and registration.