Last July 24, 2024, Thailand FDA released an infographic about Advertisement of Medical Devices Direct to Health Professionals. The summary of the information is as follows:
Advertising medical devices that are exempt from authorization to healthcare professionals is a form of direct advertising with specific characteristics and methods aimed only at healthcare and public health professionals. Advertising must be reported directly to professionals via Form Jor.Kor. through the E-submission system.
The following actions will be considered non-compliant advertising to the Food and Drug Administration:
- Not specifying the location and time period for broadcasting advertisements in Form Jor.Kor. Item 3, and not specifying the method of accessing advertisements specifically for healthcare and public health professionals in Form Jor.Kor. Item 4.
- The advertisement does not contain the phrase “Direct advertising to healthcare professionals that is exempt from permission” or similar clear wording (e.g. using small font size compared to the overall advertisement, using faded colors, or using a font color similar to the background).
- The advertisement content violates Section 59 of the Medical Device Act.
- The advertisement is directed at the general public, or its characteristics are not limited to healthcare professionals only. General public can access -> Registrants must apply for permission to advertise medical devices.
- The medical device name and license number in Form Jor.Kor. Item 1 do not exactly match the medical device details appearing in the advertisement.
After notifying the authority on the direct advertisement to healthcare professionals, you can publish the advertisement. You must comply with the Ministry’s announcement on criteria, methods, and conditions for advertising medical devices directly to healthcare and public health professionals exempt from authorization in 2020, and advertising must not violate Section 59 of the Medical Device Act 2008. The FDA will conduct post-audit checks.
For more information, refer to the infographic below from TFDA website and the following link.
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