New Taiwan Medical Device Law includes strict new regulations on import, distribution

Medical device manufacturers face new regulations on the sale and distribution of their products in Taiwan, under a law put into effect by the country’s president in January. The Medical Device Management Act is wide-ranging. It tightens the classification system of medical devices by Taiwan’s Food and Drug Administration, and among other key provisions mandates that medical device firms and institutions establish, maintain and report data on their supply sources and the flow of their products. Medical device manufacturers are also required to set up distribution systems that comply with the regulations, which require inspections and distribution licenses.