Thailand to Regulate Hand Sanitizer as a Medical Device
The Thai Food and Drug Administration (FDA) announced that hand sanitizer (alcohol gel) will require registration as a medical device (reference press released number สธ 1007/ว706 dated January 17, 2019). The change is expected to take place later this year when the new medical device classification guidelines are implemented.
Since 2011, hand sanitizer with alcohol content of 62.4% by weight or greater has required registration as a cosmetic device with the Bureau of Cosmetic and Hazardous Substances. When the new medical device classification system is implemented alcohol gel products will need to be registered with Medical Device Department of the Thai FDA. At that time notified alcohol gel certifications issued by the Bureau of Cosmetic and Hazardous Substances will be cancelled.
The move to change the status of hand sanitizers was deemed necessary to prevent insufficiently strong products from being inappropriately used as a disinfectant in department stores, schools or hospitals to prevent the spread of contagious diseases.
Contact Asia Actual for more information about how to register medical devices in Thailand.