The Taiwan Food and Drug Administration (FDA) has published guidance dedicated to the state registration of the medical devices subject to reprocessing. The document describes the procedures related to premarket review, examination, and registration of single-use...
Taiwan Food and Drugs Administration (FDA) has published draft guidance covering the regulations related to the special measures to be taken to ensure the safety of medical devices in the context of post-market surveillance. Together with the guidance on adverse event...
The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan. In particular, the documents are covering the aspects related to the adverse events...