Taiwan – TFDA outlines new UDI requirements for medical devices in draft guidance

The Taiwan Food and Drug Administration (TFDA) published a draft guidance document (link in Chinese) for public consultation on November 5. The guidance ​​outlines new requirements relating to the creation and application of Unique Device Identification (UDI) information for medical devices and IVDs.

Guidance addresses UDI labeling and uploading information to database

Under the new requirements, Class II and III medical devices and IVDs will need to be labeled with UDI information on the body of the product itself or on individual packages. In cases where the product is too small for this condition to be feasible, the UDI labeling may be applied to the smallest unit of bulk packaging used for sale. The guidance also lists certain types of products that are exempt from UDI labeling requirements, including personalized medical devices…