With Special Announcement No. 136 the Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.
This change was announced on September 13, 2019 for immediate effect. Products covered by an existing Import License will retain market access until its expiry. All new or renewal applications are subject to the new requirements.
The requirements apply to devices intended for sterilization of human or animal skin or medical formulated from ethyl alcohol or ethanol (minimum of 70% by volume). Government processing fees will depend on device classification as per the table below. Processing times are targeted at 6 months.
|Class 1||THB 25,000 (US$740)|
|Class 2||THB 38,000 (US$1,120)|
|Class 3||THB 63,000 (US$1850)|
|Class 4||THB 88,000 (US$2,590)|
Contact Asia Actual for more information regarding regulatory changes in Thailand