The Thai FDA is preparing to charge a fee for the Expert Review procedure of the Import License application process. Currently there is no additional fee for the Expert Review that is applied to the registration process for high and medium risk devices and certain low risk devices.
The application of the new fee is to correspond with adoption of a new device classification system based on ASEAN Medical Devices Directive guidelines. Then the Expert Review fees would vary by device classification, as below:
- Class 1 – THB 0 or THB 25,000 (US$740)
- Class 2 – THB 38,000 (US$1,120)
- Class 3 – THB 63,000 (US$1,850)
- Class 4 – THB 88,000 (US$2,590)
Implemented is expected to begin as early as August.