www.fdanews.com/articles/185215-taiwan-fda-advances-first-medical-device-act
Taiwan FDA Advances First Medical Device Act
January 16, 2018
Taiwan recently took a major step in advancing legislation that would revamp how its medical device system is regulated.
The Republic of China’s Executive Yuan approved the Medical Devices Act draft, issued last summer by the Taiwan Food and Drug Administration, and recommended it to the Legislative Yuan in mid-December.
The act recognizes that Taiwanese regulations on medical devices should be separated from the Pharmaceutical Affairs Act of 1993.