The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has issued guidance clarifying the circumstances in which certain medical device advertisements may be exempt from prior advertising approval.
The exemption applies only where specified event, organizer, attendance, and notification conditions are met. Advertising materials must still comply with applicable Thai FDA requirements even when prior approval is not required.
Read the Thai FDA guidance here:
https://medical.fda.moph.go.th/press-release/advertisementexemption
Purpose of the Guidance
To clarify when medical device advertising displayed at eligible exhibitions, trade fairs, scientific meetings, or conferences may be exempt from prior Thai FDA advertising approval.
The guidance also outlines the conditions, compliance requirements, and information required for the exemption pathway.
Conditions for Advertising Exemption
Advertisements may qualify for exemption from prior approval where all of the following conditions are met:
- The advertisement is displayed at a national or international exhibition, trade fair, scientific meeting, or conference with academic content.
- The event is organized by a government agency, the Thai Red Cross Society, a Royal College, or a medical or public health academic institution.
- The event is attended by at least 100 participants.
- The event organizer has notified the Thai FDA in advance.
Where these conditions are not met, the advertisement remains subject to the applicable Thai FDA advertising approval requirements.
Requirements That Still Apply
Even where prior advertising approval is not required, companies must continue to comply with the following requirements.
Product Compliance
The advertised medical device must have a valid manufacturing or import license in accordance with Section 27 of the Medical Device Act.
Advertising Content
Advertising content must comply with Section 59 of the Medical Device Act.
The advertisement must not be false, exaggerated, misleading, or likely to cause misunderstanding.
Venue and Duration
Advertisements qualifying for the exemption may only be displayed:
- Within the exhibition or event venue
- During the period of the exhibition, trade fair, scientific meeting, or conference
Required Information
Product Information
Product information should be submitted in Excel format and include:
- Medical device name
- Manufacturer country
- Product owner
The file size must not exceed 10 MB.
Event Information
The following event details are required:
- Event name
- Venue or location
- Date and time of the event
Organizer Information
Organizer information should include:
- Name of the organizing entity
- Address
- Business Registration Number
- Event notification letter in PDF format
Implications to Clients
Manufacturers, importers, and distributors may benefit from reduced administrative requirements when advertising medical devices at eligible exhibitions, conferences, or scientific meetings.
Companies should assess whether planned promotional activities meet all exemption conditions before relying on the exemption pathway.
Advertising materials must still comply with Thai FDA product and advertising requirements even where prior approval is not required.
Where an event or advertisement does not satisfy the exemption criteria, the applicable Thai FDA advertising approval must be obtained before the material is used.
Effective Date
Informational guidance only.
No new regulatory requirements or specific effective date have been announced.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.