The new “Medical Devices Act” is set to come into effect on May 01, 2021. This law was announced on January 15, 2020. Earlier medical devices were regulated by the Pharmaceutical Affairs Act, but now they will be part of the Medical Devices Act. Details about clinical trials on medical devices are included in Chapter IV, Article 37-39.
Medical device clinical trials conducted in Taiwan need prior approval from the Taiwan FDA. Sponsors will need to report any serious or life-threatening adverse events related to medical device clinical trials conducted in Taiwan. Even though the regulation includes a generic term called ‘information disclosure’, it has not been elaborated further.