Taiwan Implements Stringent New Identification Requirements for Labeling of Medical Devices

Medical device manufacturers will be required to include unique identification (UDI) codes on the labels of their products sold in Taiwan beginning May 1, under new medical device regulations established by the government.

The requirements, released in draft form in January and anticipated for several years, will be enforced by the Taiwan Food and Drug Administration. They mandate that UDI labels include a host of identifiers, including license and serial numbers, license type and expiration date, batch numbers, and date of manufacture.

The UDI labels will be required in June this year for high-risk Class III implantable devices, a year later for Class III non-implantable devices, and by June 2023 for Class II moderate-risk devices. The UDI codes must be carried on the actual package or body of Class II and Class III medical devices, or on the smallest unit of the device available for sale.