February 2021

The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021 and the remainder comes into effect on 17th March 2021. The new regulations include changes in product classification for both IVD and non-IVD medical devices, types and stages of submission, groupings of medical devices, registration […]

All medical devices to enter Thailand, whether manufactured domestically or imported, are regulated by the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Currently, the registration of medical devices is classified according to the level of control, which lists 3 levels: Licensed Medical Devices Notified Medical Devices General Medical Devices. Registrations