Taiwan – Taiwan regulator releases draft guidances for medical device vigilance reporting

The Taiwan Food and Drug Administration (TFDA) published two draft guidance documents for public consultation on October 8, offering updated information on post-market surveillance and reporting procedures.

Draft guidances detail medical device vigilance reporting procedures

The first guidance, Medical Device Safety Surveillance Management Measures (links in Mandarin), defines the requirements surrounding submission to the TFDA of Periodic Safety Update Reports (PSURs). These reports have generally been required for the first three years that a new device is on market in Taiwan…