Taiwan – New Taiwanese medical device regulations set for May 2021

The Taiwanese government plans to launch new medical device regulations on May 1, 2021, ushering in new requirements for unique device identification (UDI), distribution and other processes.

The Medical Devices Act (link in Chinese) establishes a new medical device regulatory framework in Taiwan via a phased implementation schedule. Some key elements of the new regulation to be enforced by the Taiwan Food and Drug Administration (TFDA) include…