On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders:
The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display.
The Signage must be displayed for the following:
- Medical device manufacturing facility
- Medical device selling facility
- Medical device importing facility
- Medical device storage facility
- At the location specified in the establishment license for medical devices / medical device sales license, which must be displayed in a clearly visible location.
- Display the sign in front of the building, fence, or area where the sign can be clearly seen from public areas.
Four types of signage requirements:
1. “Medical Device Import Facility”
- Font size not less than 3 cm in height with white letters
- Background color: Green
- Sign size: Not less than 20 cm high, not less than 70 cm wide
2. “Medical Device Manufacturing Facility”
- Font size not less than 3 cm in height with white letters
- Background color: Blue
- Sign size: Not less than 20 cm high, not less than 70 cm wide
3. “Medical Device Storage Facility”
- Font size not less than 3 cm in height with white letters
- Background color: Red
- Sign size: Not less than 20 cm high, not less than 70 cm wide
4. “Medical Device Selling Facility” (Only for medical device under sales license)
- Font size not less than 3 cm in height with white letters
- Background color: Orange
- Sign size: Not less than 20 cm high, not less than 70 cm wide
For more information, refer to this link and “Announcement of the Ministry of Public Health on Criteria, Procedures, and Conditions for Displaying Signs at Manufacturing, Importing, Selling, or Storage Facilities B.E. 2564 (2021)”.
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