The Ministry of Public Health (MOPH) of Thailand issued a draft guidance specifying information that should be displayed on a sign at the production, import, or sale site of certain types of medical devices. It is mentioned in the draft guidance that the sign shall include:
- The name and surname of the production, import, or sale controller;
- The qualifications of the production, import, or sale controller.
The sign must be at least 20 centimetres (8 inches) wide and 50 centimetres (20 inches) long, and it must be written in Thai. The sign must be made of a permanent white material and the text must be in blue Thai characters that are at least 3 centimetres (1.2 inches) high.
This draft guidance will apply to the following types of medical devices:
- Viscous products for use in eye surgery
- Silicone breast implants for implantation in the body
- Hyaluronic acid injections for the correction of skin defects
The draft guidance will come into effect in 1 (one) year after the date of its publication in the Government Gazette. Further information on the draft guidance can be found in the translated document that can be accessed here.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.