Taiwan – Taiwan update: Classification scheme, final fee schedule, post-market surveillance measures

Taiwan’s Medical Devices Act, which replaces the country’s former regulatory framework for medical devices, went into effect on May 1. But while the law is now operative, not all of the new developments relating to it have been immediately clear. The Taiwan Food and Drug Administration (TFDA) has continued to release a rapid series of announcements and guidance documents to provide clarity to manufacturers and other stakeholders, and Emergo by UL has accordingly prepared a third roundup of newly provided information about the regulations. For more background, please see the initial announcement of the law and our first and second roundups…