Medical Device Control Division would like to inform entrepreneurs to follow the guidelines for displaying warnings, prohibitions, and precautions in advertising medical devices in accordance with the Thai FDA announcement. The criteria, methods and conditions for issuing licenses and medical device advertising license 2021 (B.E. 2564), with details according to the manual for requesting permission to advertise medical devices as follows:
| Display of warnings, contraindications and cautions according to various types of advertising media | |
|---|---|
| Print and internet media without sound: | Radio broadcasting: |
| 1. The font size must not be less than 1/4 of font size of main point | 1. Pronunciation for warnings need to speak out with the same cadence and speed as advertising messages. |
| 2. The height must be at least 2 millimeters. | |
| 3. The letters must have a color that contrasts with the background and be easy to read. | |
| Billboard | Television radio |
| 1. The font size must not be less than 1/3 of the maximum font size. | 1. The font size must not be less than 1/25 of the height of the screen and be displayed as “Super”, showing not less than 5 seconds, with a color contrasting with the background color. |
| 2. The color contrasts with the background for clarity. | |
Entrepreneurs who wish to advertise medical devices must strictly adhere to regulations. If advertising is not followed, all advertising will be considered disapproved and a violation of Section 57 of the Medical Device Act 2008 (B.E. 2551) and its amendments. It shall be subject to be a fine of no more than 50,000 Baht or a maximum term of imprisonment of six months, or both.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.